NCT01503021

Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis

A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Multicenter Phase III Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in Chronic Kidney Disease Patients Receiving Chronic Hemodialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 718 (actual)
• Sponsor: Rockwell Medical Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the parent study is to assess the short-term safety and tolerability of soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic kidney disease patients on hemodialysis (CKD-HD). The purpose of the extension study is to assess the long-term safety and tolerability of SFP.

Detailed description

Parent Study: randomized, double-blinded, crossover, up to 6 weeks, 700 patients. Patients were randomized to receive SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate or placebo (standard liquid bicarbonate concentrate) x 2 weeks, then a 1 week washout, then crossed over to the alternate treatment x 2 weeks. Extension Study: open-label, single active arm, uncontrolled study, up to 53 weeks, 300 patients. Following completion of the RMTI-SFP-6 parent study, patients could enter the extension study, where they received SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate for up to 52 weeks.

Conditions

• End Stage Renal Disease
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	SFP	Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
OTHER	Placebo	Dialysis with standard liquid bicarbonate concentrate without iron

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-01-02
• Last updated: 2016-10-25
• Results posted: 2015-04-21

Locations

31 sites across 2 countries: United States, Canada