CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 131 enrolled
Drug / intervention
Soluble Ferric Pyrophosphate +4 moredrug
Likely dose
Soluble Ferric Pyrophosphate 5 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/NCT00548249
NCT00548249Phase 2Completed
CompareCT.gov

A Dose Ranging Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) Versus Control in Subjects With ESRD Receiving Chronic Hemodialysis.

Rockwell Medical Technologies, Inc.·interventional·Posted Oct 23, 2007·Updated Dec 2, 2020

In Brief

A Phase 2 clinical trial evaluating Standard Bicarbonate Solution and Soluble Ferric Pyrophosphate for End-Stage Renal Disease (ESRD). Completed, enrolled 131 participants across 28 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd-Stage Renal Disease (ESRD)
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 23, 2007
Enrollment StartAug 1, 2007
Primary CompletionOct 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.7 years ago

Interventions

Standard Bicarbonate Solutiondevice

Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

Soluble Ferric Pyrophosphatedrug

Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

Soluble Ferric Pyrophosphatedrug

Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

Soluble Ferric Pyrophosphatedrug

Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

Soluble Ferric Pyrophosphatedrug

Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.