## Protocol Section
### Identification Module
**NCT ID:** NCT01128179

**Brief Title:** Effects of Lanthanum Carbonate on FGF-23 in Subjects With Stage 3 CKD

**Official Title:** A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo-controlled Study to Assess the Effect of Lanthanum Carbonate on Intact FGF23 in Normo-phosphataemic Subjects With Stage 3 Chronic Kidney Disease

#### Organization Study ID Info
**ID:** SPD405-703
#### Organization
**Class:** INDUSTRY
**Full Name:** Takeda
#### Secondary ID Infos
**ID:** 2009-016531-35
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2012-04-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-06-09

**Type:** ACTUAL

**Last Update Submit Date:** 2021-05-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-04-16

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2013-05-22

**Type:** ESTIMATED

**Results First Submit Date:** 2013-03-20

**Results First Submit QC Date:** 2013-03-25

#### Start Date
**Date:** 2010-12-06

**Type:** ACTUAL

**Status Verified Date:** 2021-05

#### Study First Post Date
**Date:** 2010-05-21
**Type:** ESTIMATED
**Study First Submit Date:** 2010-05-20
**Study First Submit QC Date:** 2010-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Shire

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.

### Conditions Module

**Conditions:**

- Chronic Kidney Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 35

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Lanthanum carbonate

**Label:** Lanthanum carbonate

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lanthanum carbonate

**Description:** 1000 mg in chewable tablets administered three times a day (for a total of 3000 mg/day) for 12 weeks

**Name:** Lanthanum carbonate

**Other Names:**

- Fosrenol/Foznol

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Matching placebo chewable tablets administered 3 times a day for 12 weeks

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.

**Measure:** Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)

**Time Frame:** 12 Weeks

#### Secondary Outcomes

**Measure:** Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)

**Time Frame:** 12 Weeks

**Measure:** Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)

**Time Frame:** 12 weeks

**Measure:** Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)

**Time Frame:** 12 weeks

**Measure:** Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)

**Time Frame:** 12 weeks

**Measure:** Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)

**Time Frame:** 12 weeks

**Measure:** Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Subjects meeting all of the criteria listed below may be included in the study:

1. ≥18 years old.
2. Male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol.
3. Been in the care of a physician for CKD for \>2 months, and are not expected to begin dialysis for at least 6 months.
4. Screening serum c-terminal FGF23 \> 50.0RU/mL.
5. Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the MDRD formula.
6. Normal serum phosphate (0.808-1.55mmol/L).
7. Endogenous 25-hydroxy Vitamin D levels \>20ng/mL.
8. Adequate protein diet (includes 2-3 portions of protein-rich food per day).
9. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
10. Ability to provide written, signed, and dated (personally) informed consent to participate in the study.

Exclusion Criteria

1. Vitamin D supplementation required.
2. Compounds containing calcium, phosphate, aluminium or magnesium required.
3. Acute renal failure.
4. Rapidly progressing glomerulonephritis.
5. Vegetarian diet.
6. Known allergy to iodine.
7. Clinically significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair subjects' ability to give informed consent or take part in or complete this clinical study.
8. Cirrhosis or other clinically significant liver disease (aspartate transaminase (AST) or alanine transaminase (ALT) \>3 times the upper limit of normal or bilirubin \>2 times the upper limit of normal).
9. Past (treated within the last 5 years) or present GI disorders including uncontrolled peptic ulcer, Crohn's disease (or other conditions where the integrity of the GI tract may be compromised), malignancy, or GI bleed within the last 6 months.
10. Life-threatening malignancy or current multiple myeloma.
11. Known to be Human Immunodeficiency Virus (HIV) positive.
12. History of poor compliance with diet or medication that in the Investigator's opinion may interfere with adherence to the protocol.
13. History of alcohol or other substance abuse within 6 months prior to screening.
14. Subjects must not have used another investigational medicinal product or taken part in a clinical trial within the last 30 days prior to enrolment.
15. Subjects who have previously been enrolled into this study and subsequently withdrawn.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Saint Ouen

**Country:** France

**Facility:** Dr Pablo Urena Torres

**State:** Paris

**Zip:** 93400

#### Overall Officials

**Official 1:**

**Affiliation:** Takeda

**Name:** Study Director

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Urena-Torres P, Prie D, Keddad K, Preston P, Wilde P, Wan H, Copley JB. Changes in fibroblast growth factor 23 levels in normophosphatemic patients with chronic kidney disease stage 3 treated with lanthanum carbonate: results of the PREFECT study, a phase 2a, double blind, randomized, placebo-controlled trial. BMC Nephrol. 2014 May 5;15:71. doi: 10.1186/1471-2369-15-71.

**PMID:** 24885942

## 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

### 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: 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: 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: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- 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

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Lanthanum Carbonate

**Description:** 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks

**ID:** EG000

**Other Num Affected:** 2

**Other Num at Risk:** 23

**Serious Number Affected:** 2

**Serious Number At Risk:** 23

**Title:** Lanthanum Carbonate

**Group ID:** EG001

**Title:** Placebo

**Description:** Matching placebo chewable tablets administered 3 times a day for 12 weeks

**ID:** EG001

**Other Num at Risk:** 12

**Serious Number At Risk:** 12

**Title:** Placebo

**Frequency Threshold:** 5

#### Other Events

**Term:** Constipation

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Cardiac failure

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 23

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Myocardial ischemia

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 23

**Group ID:** EG001

**Num At Risk:** 12

**Term:** Pancreatitis acute

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 23

**Group ID:** EG001

**Num At Risk:** 12

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 23

**Group ID:** BG001

**Value:** 12

**Group ID:** BG002

**Value:** 35

**Units:** Participants

### Group

**ID:** BG000

**Title:** Lanthanum Carbonate

**Description:** 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Matching placebo chewable tablets administered 3 times a day for 12 weeks

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 13.9

**Value:** 66.0

#### Measurement

**Group ID:** BG001

**Spread:** 13.2

**Value:** 69.4

#### Measurement

**Group ID:** BG002

**Spread:** 13.6

**Value:** 67.2

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 23

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 35

**Class Title:** >=18 years

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 17

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 18

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 23

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 35

**Class Title:** France

**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:** Age, Customized
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
**Population Description:** The Safety Analysis Set was defined as all randomized subjects who received at least 1 dose of investigational product. This population was used in all safety reporting.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** ClinicalTransparency@shire.com
**Organization:** Shire
**Phone:** +1 866 842 5335
**Title:** Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -0.3389
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.1146
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Assuming that the natural logarithm transformed serum intact FGF-23 is normally distributed with a mean of 3.5 and a standard deviation of 0.46, 33 subjects randomised 2:1 (lanthanum carbonate to placebo) will be sufficient to detect with 80% power at the 5% 2-sided significance level a decrease of 0.5 in the mean difference (placebo minus lanthanum carbonate) of the log-transformed data at Week 12.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.3186
**P-Value Comment:** The a priori significance level was 5%. There was no adjustment for multiple comparisons.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.1121
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -6.15
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 19.23
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of serum iPTH at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline iPTH as a covariate. The study was not powered for the analysis of this parameter.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.2995
**P-Value Comment:** The p-value was unadjusted and had no a priori significance level.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 6.54
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -5.36
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 15.57
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of 1,25-Dihydroxy Vitamin D at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline 1,25-Dihydroxy Vitamin D as a covariate. The study was not powered for the analysis of this parameter.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.3252
**P-Value Comment:** The p-value was unadjusted and had no a priori significance level.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 5.11
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -8.845
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.403
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Urinary Fractional Excretion of Phosphate at Week 12 (LOCF) when utilizing an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Urinary Fractional Excretion of Phosphate as a covariate. The study was not powered for the analysis of this parameter.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.1459
**P-Value Comment:** The p-value was unadjusted and had no a priori significance level.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -3.7
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -0.1492
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.0897
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Phosphate at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Phosphate as a covariate. The study was not powered for the analysis of this parameter
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.6134
**P-Value Comment:** The p-value was unadjusted and had no a priori significance level.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.0297
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** -0.0739
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.1328
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Serum Total Calcium at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Serum Total Calcium as a covariate. The study was not powered for the analysis of this parameter.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.5636
**P-Value Comment:** The p-value was unadjusted and had no a priori significance level.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 0.0294
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** -0.2811
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.2553
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** The null hypothesis was that there would be no difference between the 2 treatment groups in the mean change from baseline of Calcium-Phosphate Product at Week 12 (LOCF) in an analysis of covariance (ANCOVA) with treatment as a factor and the baseline Calcium-Phosphate Product as a covariate.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.9220
**P-Value Comment:** The p-value was unadjusted and had no a priori significance level.
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** -0.0129
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0709
- **Upper Limit:** 
- **Value:** 4.0089
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0844
- **Upper Limit:** 
- **Value:** 4.1210
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.96
- **Upper Limit:** 
- **Value:** 1.67
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.72
- **Upper Limit:** 
- **Value:** -4.87
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.22
- **Upper Limit:** 
- **Value:** -1.75
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.85
- **Upper Limit:** 
- **Value:** -6.86
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.5
- **Upper Limit:** 
- **Value:** -5.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** -2.2
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0371
- **Upper Limit:** 
- **Value:** 0.0053
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0443
- **Upper Limit:** 
- **Value:** 0.0350
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0323
- **Upper Limit:** 
- **Value:** 0.0242
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0385
- **Upper Limit:** 
- **Value:** -0.0052
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0833
- **Upper Limit:** 
- **Value:** 0.0581
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0993
- **Upper Limit:** 
- **Value:** 0.0710
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** Per-protocol (PP) set are subjects who received at least 1 dose of investigational product and who had primary data assessment available from Week 2 or later and who did not have pre-defined major protocol deviations that could have affected the primary variable.
**Reporting Status:** POSTED
**Time Frame:** 12 Weeks
**Title:** Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)
**Type:** PRIMARY
**Unit of Measure:** pg/ml
##### Group
**Description:** 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
**ID:** OG000
**Title:** Lanthanum Carbonate
##### Group
**Description:** Matching placebo chewable tablets administered 3 times a day for 12 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** PP
**Reporting Status:** POSTED
**Time Frame:** 12 Weeks
**Title:** Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)
**Type:** SECONDARY
**Unit of Measure:** pg/ml
##### Group
**Description:** 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
**ID:** OG000
**Title:** Lanthanum Carbonate
##### Group
**Description:** Matching placebo chewable tablets administered 3 times a day for 12 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** PP
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)
**Type:** SECONDARY
**Unit of Measure:** pg/ml
##### Group
**Description:** 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
**ID:** OG000
**Title:** Lanthanum Carbonate
##### Group
**Description:** Matching placebo chewable tablets administered 3 times a day for 12 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 4
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** PP
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)
**Type:** SECONDARY
**Unit of Measure:** percentage of excretion of phosphate
##### Group
**Description:** 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
**ID:** OG000
**Title:** Lanthanum Carbonate
##### Group
**Description:** Matching placebo chewable tablets administered 3 times a day for 12 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 5
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** PP
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)
**Type:** SECONDARY
**Unit of Measure:** mmol/L
##### Group
**Description:** 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
**ID:** OG000
**Title:** Lanthanum Carbonate
##### Group
**Description:** Matching placebo chewable tablets administered 3 times a day for 12 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 6
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** PP
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)
**Type:** SECONDARY
**Unit of Measure:** mmol/L
##### Group
**Description:** 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
**ID:** OG000
**Title:** Lanthanum Carbonate
##### Group
**Description:** Matching placebo chewable tablets administered 3 times a day for 12 weeks
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 7
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** PP
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)
**Type:** SECONDARY
**Unit of Measure:** mmol^2/L^2
##### Group
**Description:** 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
**ID:** OG000
**Title:** Lanthanum Carbonate
##### Group
**Description:** Matching placebo chewable tablets administered 3 times a day for 12 weeks
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
**ID:** FG000
**Title:** Lanthanum Carbonate
#### Group
**Description:** Matching placebo chewable tablets administered 3 times a day for 12 weeks
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 23
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 12
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 21
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 12
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True