NCT01736397

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Keryx Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Iron Deficiency
• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Ferric Citrate	Dose depends on serum phosphorus levels collected at each study visit.
DRUG	Placebo

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2012-11-29
• Last updated: 2017-10-20
• Results posted: 2017-10-20

Locations

20 sites across 1 country: United States