NCT01191255

A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

A Three-Period, 58-Week Safety and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 441 (actual)
• Sponsor: Keryx Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.

Detailed description

This trial is a three-period, multicenter, safety and efficacy clinical trial. The first period is a two-week Washout Period, the second period is a 52-week randomized, open-label, active control Safety Assessment Period, and the third period is a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period in only the patients who were randomized to treatment with ferric citrate during the Safety Assessment Period. The primary objectives of this trial are to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with ESRD undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in the four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period.

Conditions

• Hyperphosphatemia
• Kidney Failure

Interventions

Type	Name	Description
DRUG	ferric citrate, ca acetate, sevelamer carbonate, placebo	All intervention doses will be based on serum phosphorus levels and/or drug label requirements

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2010-08-30
• Last updated: 2014-12-10
• Results posted: 2014-12-10

Locations

56 sites across 3 countries: United States, Israel, Puerto Rico