NCT01322347

Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)

A Randomized, Placebo-Controlled, Phase III Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) in Chronic Kidney Disease Patients Receiving Hemodialysis: The Continuous Replacement Using Iron Soluble Equivalents (CRUISE 2) Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Rockwell Medical Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the change from baseline in hemoglobin (Hgb).

Detailed description

Screening: 2-3 weeks prior to enrollment in Stage 1. Stage 1 (Run-In): 1-4weeks depending on qualification for Stage 2. Stage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely. Stage 3 (Open-Label Treatment): The duration of Stage 2 plus Stage 3 is intended to be 18 months regardless of treatment assignment in Stage 2.

Conditions

• Renal Failure Chronic Requiring Hemodialysis

Interventions

Type	Name	Description
DRUG	Soluble Ferric Pyrophosphate (SFP)	Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.
DEVICE	Standard dialysate	Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-01-01
• Completion: 2014-02-01
• First posted: 2011-03-24
• Last updated: 2017-04-26
• Results posted: 2015-04-24

Locations

40 sites across 2 countries: United States, Canada