## Protocol Section
### Identification Module
**NCT ID:** NCT01704079

**Brief Title:** Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency

**Official Title:** A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of CTAP101 Capsules to Treat Secondary Hyperparathyroidism in Subjects With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

#### Organization Study ID Info
**ID:** CTAP101-CL-3002
#### Organization
**Class:** INDUSTRY
**Full Name:** OPKO Health, Inc.
### Status Module
#### Completion Date
**Date:** 2014-09

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2015-11-16

**Type:** ESTIMATED

**Disp First Submit Date:** 2015-10-22
**Disp First Submit QC Date:** 2015-10-22

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-12-18

**Type:** ACTUAL

**Last Update Submit Date:** 2019-12-17

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-08

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-08-17

**Type:** ESTIMATED

**Results First Submit Date:** 2016-07-08

**Results First Submit QC Date:** 2016-07-08

#### Start Date
**Date:** 2012-11

**Status Verified Date:** 2019-12

#### Study First Post Date
**Date:** 2012-10-11
**Type:** ESTIMATED
**Study First Submit Date:** 2012-10-06
**Study First Submit QC Date:** 2012-10-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** OPKO IP Holdings II, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated

**Detailed Description:** This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CTAP101 Capsules administered for 26 weeks to treat SHPT in subjects ≥18 years of age with stage 3 or 4 CKD and vitamin D insufficiency. The study will be conducted at approximately 40 sites within the United States (US). Approximately 550 subjects will be screened to randomize approximately 210 eligible subjects, stratified by CKD stage (approximately 105 subjects in each stage) in a 2:1 ratio to receive either CTAP101 Capsules or matching placebo. An Interactive Voice Response System (IVRS) will provide study treatment group assignments using the computer-generated randomization code provided by the IVRS vendor. Subjects will receive an initial daily dose of 1 capsule (CTAP101 Capsules, 30 µg, or matching placebo) for the first 12 weeks. After l2 weeks (visit 8) and per pre-defined criteria, the dose may be increased in a blinded fashion by the IVRS with oversight by an independent medical monitor.

### Conditions Module

**Conditions:**

- Chronic Kidney Disease

- Hyperparathyroidism, Secondary

- Vitamin D Deficiency

**Keywords:**

- Parathyroid Diseases

- Renal Insufficiency

- Kidney Failure, Chronic

- Hyperparathyroidism, Secondary

- Vitamin D

- Hyperparathyroidism

- Kidney Diseases

- Kidney Failure

- Renal Insufficiency, Chronic

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 216

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.

**Intervention Names:**

- Drug: CTAP101 30 μg capsules

- Other: Sugar pill to CTAP101 30 μg capsules

**Label:** CTAP101 30 μg capsules

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.

**Intervention Names:**

- Other: Sugar pill to CTAP101 30 μg capsules

**Label:** Sugar pill to CTAP101 30 μg

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CTAP101 30 μg capsules

**Description:** CTAP101 30 μg capsule taken daily at bedtime

**Name:** CTAP101 30 μg capsules

**Other Names:**

- Calcifediol

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- CTAP101 30 μg capsules

- Sugar pill to CTAP101 30 μg

**Description:** Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.

**Name:** Sugar pill to CTAP101 30 μg capsules

**Other Names:**

- Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Number of subjects in the intent to treat population attaining mean decrease in plasma intact Parathyroid Hormone (iPTH) of ≥30% from P\\pre-treatment baseline in the efficacy assessment phase (EAP) referred to as responders

**Measure:** Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline

**Time Frame:** Approximately 6 months

#### Secondary Outcomes

**Description:** Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders

**Measure:** Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline

**Time Frame:** Approximately 6 months

**Description:** Subjects in the intent to treat population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/dL)

**Measure:** Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D

**Time Frame:** Approximately 6 months

**Description:** Subjects in the per protocol population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/mL)

**Measure:** Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D

**Time Frame:** Approximately 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Urinary albumin excretion ≤ 3000 mcg/mg of creatinine
2. Stage 3 or 4 CKD
3. Plasma iPTH: ≥ 85 pg/mL and \< 500 pg/mL
4. Serum Ca: ≥ 8.4 mg/dL and \< 9.8 mg/dL
5. Serum P: ≥ 2.0 mg/dL and \< 5.0 mg/dL
6. Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and \< 30 ng/mL.
7. Stable dose of Vitamin D therapy ≤ 1600 IU/day and receiving same dose for at least 2 months

Exclusion Criteria:

1. History of kidney transplant or parathyroidectomy
2. Spot urine calcium:creatinine ratio \> 0.2 (\>200 mg/g Cr)
3. Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event or hepatitis
4. Currently on dialysis
5. Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcg per month) during the study

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bannockburn

**Country:** United States

**Facility:** OPKO Renal

**State:** Illinois

**Zip:** 60015

#### Overall Officials

**Official 1:**

**Affiliation:** OPKO Renal

**Name:** Joel Melnick, MD

**Role:** STUDY_DIRECTOR

## 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: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000009369

- Term: Neoplasms

- ID: D000001361

- Term: Avitaminosis

- ID: D000003677

- Term: Deficiency Diseases

- ID: D000044342

- Term: Malnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000010279

- Term: Parathyroid Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

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

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Kidney Disease

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: HIGH

- As Found: Chronic Kidney Disease

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Secondary

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M17551

- Name: Vitamin D Deficiency

- Relevance: HIGH

- As Found: Vitamin D Deficiency

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M10012

- Name: Hyperparathyroidism

- Relevance: HIGH

- As Found: Hyperparathyroidism

- ID: M10013

- Name: Hyperparathyroidism, Secondary

- Relevance: HIGH

- As Found: Hyperparathyroidism, Secondary

- ID: M13192

- Name: Parathyroid Diseases

- 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: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

- ID: M4660

- Name: Avitaminosis

- Relevance: LOW

- As Found: Unknown

- ID: M6879

- Name: Deficiency Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25306

- Name: Malnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009362

- Term: Neoplasm Metastasis

- ID: D000007674

- Term: Kidney Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000014808

- Term: Vitamin D Deficiency

- ID: D000006961

- Term: Hyperparathyroidism

- ID: D000006962

- Term: Hyperparathyroidism, Secondary

### Intervention Browse Module - Ancestors

- ID: D000014815

- Term: Vitamins

- ID: D000018977

- Term: Micronutrients

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000050071

- Term: Bone Density Conservation Agents

### Intervention Browse Module - Browse Branches

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Vi

- Name: Vitamins

### Intervention Browse Module - Browse Leaves

- ID: M17550

- Name: Vitamin D

- Relevance: LOW

- As Found: Unknown

- ID: M6003

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: M17558

- Name: Vitamins

- Relevance: LOW

- As Found: Unknown

- ID: M5375

- Name: Calcifediol

- Relevance: HIGH

- As Found: Risk Population

- ID: M13194

- Name: Parathyroid Hormone

- Relevance: LOW

- As Found: Unknown

- ID: M21009

- Name: Micronutrients

- Relevance: LOW

- As Found: Unknown

- ID: M16885

- Name: Trace Elements

- Relevance: LOW

- As Found: Unknown

- ID: T442

- Name: Cholecalciferol

- Relevance: LOW

- As Found: Unknown

- ID: T479

- Name: Vitamin D3

- Relevance: LOW

- As Found: Unknown

- ID: T440

- Name: Calciferol

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002112

- Term: Calcifediol

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Sugar Pill to CTAP101 30 μg

**Description:** 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.

**ID:** EG000

**Other Num Affected:** 18

**Other Num at Risk:** 72

**Serious Number Affected:** 11

**Serious Number At Risk:** 72

**Title:** Sugar Pill to CTAP101 30 μg

**Group ID:** EG001

**Title:** CTAP101 30 μg Capsules

**Description:** 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.

CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.

**ID:** EG001

**Other Num Affected:** 32

**Other Num at Risk:** 144

**Serious Number Affected:** 22

**Serious Number At Risk:** 144

**Title:** CTAP101 30 μg Capsules

**Frequency Threshold:** 5

#### Other Events

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Oedema peripheral

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Nasopharyngitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

**Term:** Gout

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Metabolic acidosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Pain in extremity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 15.0

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

#### Serious Events

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 144

**Num Events:** 2

**Term:** Acute myocardial infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Cardiac arrest

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Cardiac disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Cardiac failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Cardiac failure acute

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Cardiac failure congestive

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 144

**Num Events:** 3

**Term:** Myocardial infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Asthenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 144

**Term:** Chest pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Device malfunction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Cholelitiasis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Cellulitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 144

**Term:** Localized infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 144

**Num Events:** 3

**Term:** Pneumonia bacterial

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 144

**Term:** Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 72

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 144

**Term:** Urinary tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Fall

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Blood creatinine increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 144

**Num Events:** 3

**Term:** Dehydration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 72

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Fluid overload

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Hyperkalaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 144

**Num Events:** 2

**Term:** Hypoglycaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 144

**Num Events:** 2

**Term:** Musculoskeletal chest pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 144

**Term:** Rhabdomyolysis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Cerebrovascular accident

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Dizziness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Encephalopathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Myasthenia gravis crisis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Status epilepticus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 144

**Term:** Syncope

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 144

**Num Events:** 2

**Term:** Thalamic infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 144

**Term:** Mental status changes

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 144

**Term:** Urinary tract obstruction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Acute pulmonary oedema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 144

**Term:** Acute respiratory failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Respiratory failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 72

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 144

**Term:** Angioedema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Deep vein thrombosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Term:** Hypertensive emergency

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 72

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 144

**Num Events:** 1

**Time Frame:** 6 months from randomization to end of therapy

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 72

**Group ID:** BG001

**Value:** 144

**Group ID:** BG002

**Value:** 216

**Units:** Participants

### Group

**ID:** BG000

**Title:** Sugar Pill to CTAP101 30 μg

**Description:** 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.

### Group

**ID:** BG001

**Title:** CTAP101 30 μg Capsules

**Description:** 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.

CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.06

**Value:** 65.3

#### Measurement

**Group ID:** BG001

**Spread:** 10.90

**Value:** 66.8

#### Measurement

**Group ID:** BG002

**Spread:** 10.63

**Value:** 66.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 39

#### Measurement

**Group ID:** BG001

**Value:** 71

#### Measurement

**Group ID:** BG002

**Value:** 110

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 33

#### Measurement

**Group ID:** BG001

**Value:** 73

#### Measurement

**Group ID:** BG002

**Value:** 106

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 72

#### Measurement

**Group ID:** BG001

**Value:** 144

#### Measurement

**Group ID:** BG002

**Value:** 216

**Class Title:** United States

**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:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** dlaidlaw@opko.com
**Organization:** OPKO Health, Inc.
**Phone:** 305-575-4172
**Title:** Douglass Laidlaw, PhD, Vice President, Medical Affairs
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 49
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 120
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 116
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Number of subjects in the intent to treat population attaining mean decrease in plasma intact Parathyroid Hormone (iPTH) of ≥30% from P\\pre-treatment baseline in the efficacy assessment phase (EAP) referred to as responders
**Parameter Type:** NUMBER
**Population Description:** Intent to treat
**Reporting Status:** POSTED
**Time Frame:** Approximately 6 months
**Title:** Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
**ID:** OG000
**Title:** Sugar Pill to CTAP101 30 μg
##### Group
**Description:** 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.

CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
**ID:** OG001
**Title:** CTAP101 30 μg Capsules
#### Outcome Measure 2
**Description:** Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders
**Parameter Type:** NUMBER
**Population Description:** Per protocol
**Reporting Status:** POSTED
**Time Frame:** Approximately 6 months
**Title:** Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
**ID:** OG000
**Title:** Sugar Pill to CTAP101 30 μg
##### Group
**Description:** 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.

CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
**ID:** OG001
**Title:** CTAP101 30 μg Capsules
#### Outcome Measure 3
**Description:** Subjects in the intent to treat population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/dL)
**Parameter Type:** NUMBER
**Population Description:** Intent to treat
**Reporting Status:** POSTED
**Time Frame:** Approximately 6 months
**Title:** Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
**ID:** OG000
**Title:** Sugar Pill to CTAP101 30 μg
##### Group
**Description:** 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.

CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
**ID:** OG001
**Title:** CTAP101 30 μg Capsules
#### Outcome Measure 4
**Description:** Subjects in the per protocol population with normal serum total 25-hydroxyvitamin D (\>/= 30 ng/mL)
**Parameter Type:** NUMBER
**Population Description:** Per protocol
**Reporting Status:** POSTED
**Time Frame:** Approximately 6 months
**Title:** Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
**ID:** OG000
**Title:** Sugar Pill to CTAP101 30 μg
##### Group
**Description:** 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.

CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
**ID:** OG001
**Title:** CTAP101 30 μg Capsules
### Participant Flow Module
#### Group
**Description:** 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
**ID:** FG000
**Title:** Sugar Pill to CTAP101 30 μg
#### Group
**Description:** 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.

CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime

Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
**ID:** FG001
**Title:** CTAP101 30 μg Capsules
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 7
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Subject noncompliance
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Withdraw
**Type:** Serum Calcium >/= 11.0 mg/dL, repeat con
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 72
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 144
##### Milestone
**Type:** Entered Extension Study
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 53
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 102
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 58
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 121
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 23
**Pre-Assignment Details:** Subjects were stratified by CKD stage and were randomized in a 2:1 ratio to receive a daily 30 μg oral dose of CTAP101 capsules (or matching placebo) for 12 weeks at bedtime. Subjects presenting on a regimen of bone metabolism therapy were to discontinue their prior treatment for at least 28 days' washout (except for bisphosphonates).
**Recruitment Details:** This multicenter study was conducted at 45 investigational sites within the US. Subjects were enrolled and treated from 04 February 2013 through 13 August 2014.
**Has Results:** True