CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 718 enrolled
Drug / intervention
SFP +1 moredrug
Likely dose
SFP 110 µgfrom 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/NCT01503021
NCT01503021Phase 3Completed
CompareCT.gov

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

Rockwell Medical Technologies, Inc.·interventional·Posted Jan 2, 2012·Updated Oct 25, 2016

In Brief

A Phase 3 clinical trial evaluating SFP and Placebo for End Stage Renal Disease and Chronic Kidney Disease. Completed, enrolled 718 participants across 31 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease, Chronic Kidney Disease
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 2, 2012
Enrollment StartNov 1, 2011
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.5 years ago

Interventions

SFPdrug

Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate

Placeboother

Dialysis with standard liquid bicarbonate concentrate without iron