Ferric Citrate in Managing Serum Phosphorus and Iron Deficiency in Anemic Chronic Kidney Disease (CKD) Subjects Not on Dialysis

Study Overview
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Brief Summary
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The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of treatment is approximately 12 weeks.

Detailed Description
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This is a randomized, double-blind, placebo-controlled, three-period, multi-center clinical trial. Following a Screening and Qualification Period and a two-week Washout Period (for those subjects entering the study on a phosphate binder), eligible subjects will be randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or placebo for up to approximately 12 weeks. The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic CKD subjects not on dialysis.

Official Title
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A Phase 2 Study of KRX-0502 (Ferric Citrate) in Managing Serum Phosphorus and Iron Deficiency in Anemic Subjects With Stage III to V Chronic Kidney Disease Not on Dialysis

Conditions
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Iron Deficiency, Iron Deficiency Anemia

Intervention / Treatment
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* Drug: Ferric Citrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage III to V Chronic Kidney Disease Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization Ferritin 300 ng/mL or less Transferrin Saturation (TSAT) 30% or less Hemoglobin >9.0 and <12.0 g/dL Must consume a minimum of 2 meals per day Exclusion Criteria: Parathyroidectomy within 24 weeks of study gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study Requirement for dialysis or kidney injury within 8 weeks of study Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating Agent, blood transfusions, and Sensipar during the study Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins History of hemochromatosis Allergy to iron products History of malignancy in last 5 years

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferric Citrate<br>Ferric citrate will be taken with or within one hour of meals or snacks. The starting dose of ferric citrate is 3 tablets/day and titrated by the subject's serum phosphorus results at each treatment visit. | Drug: Ferric Citrate<br>* Dose depends on serum phosphorus levels collected at each study visit.<br>* Other names: KRX-0502;|
| Placebo Comparator: Placebo<br>Placebo will be taken with or within one hour of meals or snacks. The starting dose of placebo is 3 tablets per day and titrated by the subject's serum phosphorus results at each treatment visit. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment | The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement. | 12 Weeks | 
| Change in Serum Phosphorus Levels From Baseline to End of Treatment | The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ferritin Levels From Baseline to End of Treatment | The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement. | 12 Weeks | 
| Change in Hemoglobin Levels From Baseline to End of Treatment | The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement. | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, Chronic Kidney Disease, Phosphorus, Iron Deficiency, Iron Deficiency Anemia, Elevated Phosphorus