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

Phase 2

Completed

• Conditions: Iron Deficiency Anemia; Iron Deficiency
• Interventions: Drug: Placebo; Drug: Ferric Citrate

• Registration Number: NCT01736397
• Lead Sponsor: Keryx Biopharmaceuticals

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Disposition First Submitted: 2015-04-13
• Disposition First Submitted QC: 2015-04-13
• Disposition First Posted: 2015-05-05
• Results First Submitted: 2017-08-17
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-20
• Last Update Submitted: 2017-09-20
• Results First Posted: 2017-10-20
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
Ferric Citrate	Ferric Citrate	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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