CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 305 enrolled
Drug / intervention
Soluble Ferric Pyrophosphate (SFP) +1 moredrug
Likely dose
Soluble Ferric Pyrophosphate (SFP) 11 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01320202
NCT01320202Phase 3Completed
CompareCT.gov

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 1) Study

Rockwell Medical Technologies, Inc.·interventional·Posted Mar 22, 2011·Updated Apr 26, 2017

In Brief

A Phase 3 clinical trial evaluating Soluble Ferric Pyrophosphate (SFP) and Standard dialysate for Renal Failure Chronic Requiring Hemodialysis. Completed, enrolled 305 participants across 47 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Failure Chronic Requiring Hemodialysis
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2011
Enrollment StartMar 1, 2011
Primary CompletionMay 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.3 years ago

Interventions

Soluble Ferric Pyrophosphate (SFP)drug

Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.

Standard dialysatedevice

Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.