## Protocol Section
### Identification Module
**NCT ID:** NCT01052779

**Acronym:** FIRST

**Brief Title:** A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

**Official Title:** Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

#### Organization Study ID Info
**ID:** FER-CKD-201
#### Organization
**Class:** INDUSTRY
**Full Name:** AMAG Pharmaceuticals, Inc.
#### Secondary ID Infos
**ID:** 2009-015630-30
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2012-04-19

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2013-04-10

**Type:** ESTIMATED

**Disp First Submit Date:** 2013-04-03
**Disp First Submit QC Date:** 2013-04-03

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-25

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-07-19

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2018-05-15

**Type:** ACTUAL

**Results First Submit Date:** 2018-03-26

**Results First Submit QC Date:** 2018-05-10

#### Start Date
**Date:** 2010-03-01

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2010-01-20
**Type:** ESTIMATED
**Study First Submit Date:** 2010-01-15
**Study First Submit QC Date:** 2010-01-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AMAG Pharmaceuticals, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).

### Conditions Module

**Conditions:**

- Iron Deficiency

- Anemia

- Kidney Disease

**Keywords:**

- Iron deficiency anemia

- Chronic kidney disease

- Feraheme

- Ferumoxytol

- Iron sucrose

- IDA

- CKD

- Venofer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 162

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received an IV injection of ferumoxytol (510 milligrams \[mg\], 17 milliliters \[mL\]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).

**Intervention Names:**

- Drug: Ferumoxytol

**Label:** Ferumoxytol

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.

Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

**Intervention Names:**

- Drug: Iron Sucrose

**Label:** Iron Sucrose

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ferumoxytol

**Description:** IV Ferumoxytol

**Name:** Ferumoxytol

**Other Names:**

- Feraheme

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Iron Sucrose

**Description:** IV Iron Sucrose

**Name:** Iron Sucrose

**Other Names:**

- Venofer

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as:

Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline)

The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method.

**Measure:** Mean Change In Hemoglobin From Baseline (Day 1) To Week 5

**Time Frame:** Baseline (Day 1), Week 5

**Description:** The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).

**Measure:** Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5

**Time Frame:** Baseline (Day 1) and up to Week 5

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Key Inclusion Criteria include:

1. Males and females ≥18 years of age
2. An estimated glomerular filtration rate \<60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis)
3. Hemoglobin \<11.0 g/deciliter (dL)
4. Transferrin saturation \<30%
5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week
6. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of the study

Exclusion Criteria:

Key Exclusion Criteria include:

1. History of allergy to IV iron
2. Allergy to 2 or more classes of drugs
3. Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
4. Hemoglobin ≤7.0 g/dL
5. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period
6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tempe

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Arizona

**Zip:** 85284

**Location 2:**

**City:** Chula Vista

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** California

**Zip:** 91910

**Location 3:**

**City:** Mountain View

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** California

**Zip:** 94041

**Location 4:**

**City:** Whittier

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** California

**Zip:** 90602

**Location 5:**

**City:** Augusta

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Georgia

**Zip:** 30901

**Location 6:**

**City:** Meridian

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Idaho

**Zip:** 83642

**Location 7:**

**City:** Evergreen Park

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Illinois

**Zip:** 60805

**Location 8:**

**City:** Shreveport

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Louisiana

**Zip:** 71101

**Location 9:**

**City:** Bethesda

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Maryland

**Location 10:**

**City:** Springfield

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Massachusetts

**Zip:** 01107

**Location 11:**

**City:** Flushing

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** New York

**Zip:** 11355

**Location 12:**

**City:** Rosedale

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** New York

**Location 13:**

**City:** Bethlehem

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Pennsylvania

**Zip:** 18017

**Location 14:**

**City:** San Antonio

**Country:** United States

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Texas

**Zip:** 78229

**Location 15:**

**City:** Antwerpen

**Country:** Belgium

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 2020

**Location 16:**

**City:** Antwerpen

**Country:** Belgium

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Zip:** 2060

**Location 17:**

**City:** Vancouver

**Country:** Canada

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** British Columbia

**Location 18:**

**City:** Richmond Hill

**Country:** Canada

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Ontario

**Location 19:**

**City:** Montréal

**Country:** Canada

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Quebec

**Zip:** H3A 1A1

**Location 20:**

**City:** Montréal

**Country:** Canada

**Facility:** For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**State:** Quebec

**Zip:** H4J 1C5

**Location 21:**

**City:** Berlin

**Country:** Germany

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 22:**

**City:** Düsseldorf

**Country:** Germany

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 23:**

**City:** Göttingen

**Country:** Germany

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 24:**

**City:** Munich

**Country:** Germany

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 25:**

**City:** Nürnberg

**Country:** Germany

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 26:**

**City:** Passau

**Country:** Germany

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 27:**

**City:** Bangalore

**Country:** India

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 28:**

**City:** Nagpur

**Country:** India

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 29:**

**City:** Pune

**Country:** India

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 30:**

**City:** Katowice

**Country:** Poland

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 31:**

**City:** Opole

**Country:** Poland

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 32:**

**City:** Radom

**Country:** Poland

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 33:**

**City:** Szczecin

**Country:** Poland

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 34:**

**City:** Warszawa

**Country:** Poland

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 35:**

**City:** Łódź

**Country:** Poland

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

**Location 36:**

**City:** London

**Country:** United Kingdom

**Facility:** For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

### References Module

#### References

**Citation:** Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014 Jun;89(6):646-50. doi: 10.1002/ajh.23712.

**PMID:** 24639149

**Citation:** Strauss WE, Dahl NV, Li Z, Lau G, Allen LF. Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia. BMC Hematol. 2016 Jul 26;16:20. doi: 10.1186/s12878-016-0060-x. eCollection 2016.

**PMID:** 27462400

**Citation:** Macdougall IC, Strauss WE, McLaughlin J, Li Z, Dellanna F, Hertel J. A randomized comparison of ferumoxytol and iron sucrose for treating iron deficiency anemia in patients with CKD. Clin J Am Soc Nephrol. 2014 Apr;9(4):705-12. doi: 10.2215/CJN.05320513. Epub 2014 Jan 23.

**PMID:** 24458078

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000019189

- Term: Iron Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000000747

- Term: Anemia, Hypochromic

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Kidney Disease

- ID: M20857

- Name: Anemia, Iron-Deficiency

- Relevance: HIGH

- As Found: Iron Deficiency

- ID: M2781

- Name: Iron Deficiencies

- Relevance: HIGH

- As Found: Iron Deficiency

- ID: M4070

- Name: Anemia

- Relevance: HIGH

- As Found: Anemia

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: HIGH

- As Found: Chronic Kidney Disease

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21177

- Name: Iron Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4077

- Name: Anemia, Hypochromic

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000000740

- Term: Anemia

- ID: D000018798

- Term: Anemia, Iron-Deficiency

- ID: D000090463

- Term: Iron Deficiencies

### Intervention Browse Module - Ancestors

- ID: D000006397

- Term: Hematinics

- ID: D000057947

- Term: Parenteral Nutrition Solutions

- ID: D000019999

- Term: Pharmaceutical Solutions

### Intervention Browse Module - Browse Branches

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

### Intervention Browse Module - Browse Leaves

- ID: M10533

- Name: Iron

- Relevance: LOW

- As Found: Unknown

- ID: M1861

- Name: Ferric Oxide, Saccharated

- Relevance: HIGH

- As Found: HIV Prevention

- ID: M26996

- Name: Ferrosoferric Oxide

- Relevance: HIGH

- As Found: Microspheres

- ID: M9485

- Name: Hematinics

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M28934

- Name: Parenteral Nutrition Solutions

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000052203

- Term: Ferrosoferric Oxide

- ID: D000077605

- Term: Ferric Oxide, Saccharated

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Ferumoxytol

**Description:** Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.

**ID:** EG000

**Other Num Affected:** 35

**Other Num at Risk:** 80

**Serious Number Affected:** 7

**Serious Number At Risk:** 80

**Title:** Ferumoxytol

**Group ID:** EG001

**Title:** Iron Sucrose

**Description:** Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.

Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

**ID:** EG001

**Other Num Affected:** 50

**Other Num at Risk:** 82

**Serious Number Affected:** 6

**Serious Number At Risk:** 82

**Title:** Iron Sucrose

**Frequency Threshold:** 1

#### Other Events

**Term:** Nasopharyngitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

**Term:** Urinary tract infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

**Term:** Muscle spasms

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Myalgia

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Pain in extremity

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Injection site pain

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Edema peripheral

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Constipation

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Diarrhoea

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Nausea

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Headache

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Parosmia

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Hypotension

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Hyperkalaemia

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Hypoglycaemia

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Cough

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Anaemia

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Vomiting

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Gout

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Dizziness

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Iron deficiency anaemia

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Cerumen impaction

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Lacrimation increased

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Abdominal pain upper

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Tooth disorder

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Toothache

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Catheter site erythema

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Feeling hot

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Injection site haematoma

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Tenderness

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Chills

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Device leakage

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Fatigue

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Feeling cold

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Injection site haemorrhage

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Medical device complication

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Thrombosis in device

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Sinusitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

**Term:** Staphylococcal abscess

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

**Term:** Urethritis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

**Term:** Burn first degree

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 13.0

**Term:** Humerus fracture

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 13.0

**Term:** Procedural hypotension

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 13.0

**Term:** Vascular graft thrombosis

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 13.0

**Term:** Arthropod bite

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 13.0

**Term:** Fall

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 13.0

**Term:** Procedural hypertension

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 13.0

**Term:** Scratch

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 13.0

**Term:** Sunburn

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 13.0

**Term:** Hyperglycaemia

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Hyperkalaemia

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Vitamin D deficiency

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Flank pain

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Back pain

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Bone pain

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Limb discomfort

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Neck pain

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Synovial cyst

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Seborrhoeic keratosis

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 13.0

**Term:** Dysgeusia

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Facial palsy

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Paraesthesia

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Unresponsive to stimuli

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Haematuria

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Nocturia

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Asthma

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Oropharyngeal pain

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Dyspnoea

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Epistaxis

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Rales

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Wheezing

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Ingrowing nail

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Acne

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Cold sweat

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Dry skin

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Ecchymosis

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Skin haemorrhage

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Treatment noncompliance

**Organ System:** Social circumstances

**Source Vocabulary:** MedDRA 13.0

**Term:** Flushing

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Hot flush

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Hypertension

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Poor veneous access

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 13.0

**Term:** Blood glucose increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 13.0

**Term:** Breath sounds abnormal

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 13.0

**Term:** Weight increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 13.0

**Term:** Blood pressure increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 13.0

**Term:** Cardiac murmur

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 13.0

**Term:** Hepatic enzyme increased

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 13.0

#### Serious Events

**Term:** Abscess limb

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 80

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 82

**Term:** Arteriovenous graft site infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 80

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 82

**Term:** Cellulitis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 80

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 82

**Term:** Gastroenteritis

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Group ID:** EG001

**Num At Risk:** 82

**Term:** Pneumonia

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 80

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 82

**Term:** Urinary tract infection

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 80

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 82

**Term:** Anastomotic haemorrhage

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Group ID:** EG001

**Num At Risk:** 82

**Term:** Seroma

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 80

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 82

**Term:** Vascular graft thrombosis

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 80

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 82

**Term:** Abdominal pain

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Group ID:** EG001

**Num At Risk:** 82

**Term:** Peritoneal adhesions

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Group ID:** EG001

**Num At Risk:** 82

**Term:** Small intestinal obstruction

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Group ID:** EG001

**Num At Risk:** 82

**Term:** Acute prerenal failure

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Group ID:** EG001

**Num At Risk:** 82

**Term:** Renal failure chronic

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 80

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 82

**Term:** Deep vein thrombosis

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Group ID:** EG001

**Num At Risk:** 82

**Term:** Hypotension

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 80

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 82

**Term:** Anaphylactic reaction

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 80

**Group ID:** EG001

**Num At Risk:** 82

**Term:** Hyperkalaemia

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 80

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 82

**Term:** Lung neoplasm

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 13.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 80

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 82

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 80

**Group ID:** BG001

**Value:** 82

**Group ID:** BG002

**Value:** 162

**Units:** Participants

### Group

**ID:** BG000

**Title:** Ferumoxytol

**Description:** Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.

### Group

**ID:** BG001

**Title:** Iron Sucrose

**Description:** Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.

Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 15.00

**Value:** 61.9

#### Measurement

**Group ID:** BG001

**Spread:** 15.16

**Value:** 63.3

#### Measurement

**Group ID:** BG002

**Spread:** 15.05

**Value:** 62.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 41

#### Measurement

**Group ID:** BG001

**Value:** 39

#### Measurement

**Group ID:** BG002

**Value:** 80

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 39

#### Measurement

**Group ID:** BG001

**Value:** 43

#### Measurement

**Group ID:** BG002

**Value:** 82

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 34

#### Measurement

**Group ID:** BG001

**Value:** 36

#### Measurement

**Group ID:** BG002

**Value:** 70

**Category Title:** Hemodialysis

#### Measurement

**Group ID:** BG000

**Value:** 46

#### Measurement

**Group ID:** BG001

**Value:** 46

#### Measurement

**Group ID:** BG002

**Value:** 92

**Category Title:** Nondialysis

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Dialysis Status
**Unit of Measure:** Participants
**Population Description:** Intent-to-Treat (ITT) Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose).
## Results Section - More Information Module
### Certain Agreement
**Other Details:** If there is no multi-site publication within 18 months after the Study has been completed or terminated at all Study sites, and all data has been received by Sponsor, the Site and SMO shall have the right to publish its results from the Study for non-commercial purposes, if submitted to Sponsor for review 60 days prior to submission of publication. Publication must remove all confidential information and may be delayed by up to 180 days to allow Sponsor to protect its interests.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** CTInterest@covispharma.com
**Organization:** AMAG Pharmaceuticals, Inc.
**Title:** Medical Information
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -0.21
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.41
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.
**Group Description:** With LOCF Imputation: The p-value and two-sided 95% confidence interval (CI) for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an analysis of variance (ANOVA) model adjusted for baseline hemoglobin level and hemodialysis status.
**Non-Inferiority Comment:** Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.
**Non-Inferiority Type:** NON_INFERIORITY
**Other Analysis Description:** 
**P-Value:** 0.515
**P-Value Comment:** The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.
**Parameter Type:** Treatment Difference
**Parameter Value:** 0.10
**Statistical Comment:** 
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -0.23
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.41
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** The 95% CI for hemoglobin change from Baseline (Day 1) was from an ANOVA model and adjusted for baseline hemoglobin level and hemodialysis status.
**Group Description:** Without Imputation (Sensitivity Analysis): The p-value and two-sided 95% CI for the treatment difference in mean change in hemoglobin from Baseline (Day 1) to Week 5 were generated based on an ANOVA model adjusted for baseline hemoglobin level and hemodialysis status.
**Non-Inferiority Comment:** Non-inferiority was concluded if the lower bound of the 95% CI was ≥-0.5 g/dL and superiority if the lower bound was ≥0 g/dL.
**Non-Inferiority Type:** NON_INFERIORITY
**Other Analysis Description:** 
**P-Value:** 0.587
**P-Value Comment:** The p-value for hemoglobin change from Baseline (Day 1) was adjusted for baseline hemoglobin level and hemodialysis status.
**Parameter Type:** Treatment Difference
**Parameter Value:** 0.09
**Statistical Comment:** 
**Statistical Method:** ANOVA
**Tested Non-Inferiority:** 
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.14
- **Upper Limit:** 
- **Value:** 0.84
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.14
- **Upper Limit:** 
- **Value:** 0.74
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.15
- **Upper Limit:** 
- **Value:** 0.89
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.15
- **Upper Limit:** 
- **Value:** 0.80
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as:

Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline)

The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** ITT Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose).
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 1), Week 5
**Title:** Mean Change In Hemoglobin From Baseline (Day 1) To Week 5
**Type:** PRIMARY
**Unit of Measure:** g/dL
##### Group
**Description:** Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.
**ID:** OG000
**Title:** Ferumoxytol
##### Group
**Description:** Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.

Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.
**ID:** OG001
**Title:** Iron Sucrose
#### Outcome Measure 2
**Description:** The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** ITT Population: Any randomized participant who had any exposure to study drug (IV ferumoxytol or IV iron sucrose).
**Reporting Status:** POSTED
**Time Frame:** Baseline (Day 1) and up to Week 5
**Title:** Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received an IV injection of ferumoxytol (510 mg, 17 mL) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 g.
**ID:** OG000
**Title:** Ferumoxytol
##### Group
**Description:** Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.

Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.
**ID:** OG001
**Title:** Iron Sucrose
### Participant Flow Module
#### Group
**Description:** Participants received an intravenous (IV) injection of ferumoxytol (510 milligrams \[mg\], 17 milliliters \[mL\]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).
**ID:** FG000
**Title:** Ferumoxytol
#### Group
**Description:** Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.

Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.
**ID:** FG001
**Title:** Iron Sucrose
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Other-Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Other-Surgery
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Withdraw
**Type:** Other-Missed Week 5 Visit
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 80
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 82
##### Milestone
**Type:** Received at Least 1 Dose of Study Drug
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 80
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 81
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 75
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 73
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 9
**Has Results:** True