A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease

Study Overview
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Brief Summary
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The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Definitive Phase III Study of the Effects of Ferric Citrate on Serum Phosphate in Subjects With End Stage Renal Disease

Conditions
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Hyperphosphatemia, End Stage Renal Disease, ESRD

Intervention / Treatment
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* Drug: ferric citrate
* Drug: ferric citrate
* Drug: ferric citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>18 years and has a diagnosis of ESRD On a three-times per week hemodialysis regimen On a stable dose of a phosphate-binding agent for at least one month prior to study entry. If on vitamin D supplementation or calcitriol, must be on a stable dose for at least one month prior to study entry. Hct >= 20% Serum Ca level of 8 mg/dL to 10.5 mg/dL Exclusion Criteria: Is pregnant or lactating Clinically significant GI disorder Has tertiary hyperparathyroidism or is immediately post-operative from a parathyroidectomy (within the first 3 months post-op or the plasma Ca is <7 mg/dL) ferritin>800 ng/mL Unstable medical condition unsuitable for the study in the opinion of investigator Has been treated with an investigational agent within 30 days of enrollment Has a history of documented iron allergy or hemochromatosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: ferric citrate<br>* 0g/day ferric citrate capsule, TID for 56 days<br>|
| Experimental: 4g/day<br>Ferric Citrate for a total daily dose of 4g | Drug: ferric citrate<br>* 4g/day ferric citrate capsule, TID for 56 days<br>|
| Experimental: 6g/day<br>Ferric Citrate for a total daily dose of 6g | Drug: ferric citrate<br>* 6 g/day ferric citrate capsule, TID for 56 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum phosphorus at Day 56 as compared to baseline |  | Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum phosphorus at Day 28 as compared to baseline |  | Day 28 | 
| Change in Ca x P product at Day 56 compared to baseline |  | Day 56 | 
| Change in Ca x P product at Day 28 compared to baseline |  | Day 28 | 
| Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56 |  | Day 56 | 
| Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28 |  | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Diseases, Kidney Failure, Chronic, Hyperphosphatemia, Urologic Diseases, Renal Insufficiency, Chronic, Renal Insufficiency, Phosphorus Metabolism Disorders