CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 108 enrolled
Drug / intervention
Soluble Ferric Pyrophosphate in liquid bicarbonate +3 moredrug
Likely dose
Soluble Ferric Pyrophosphate in liquid bicarbonate 11 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/NCT01286012
NCT01286012Phase 2Completed
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Physiological Iron Maintenance in End Stage Renal Disease (ESRD) Subjects by Delivery of Soluble Ferric Pyrophosphate (SFP) Via Hemodialysate: The PRIME Study

Rockwell Medical Technologies, Inc.·interventional·Posted Jan 31, 2011·Updated Oct 1, 2018

In Brief

A Phase 2 clinical trial evaluating Soluble Ferric Pyrophosphate in liquid bicarbonate, Placebo: Conventional liquid bicarbonate, and 2 other interventions for End Stage Renal Disease. Completed, enrolled 108 participants across 23 sites in 2 countries.

Detailed Summary

The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb) levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who receive conventional dialysate without iron.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2011
Enrollment StartJan 1, 2011
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.4 years ago

Interventions

Soluble Ferric Pyrophosphate in liquid bicarbonatedrug

Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.

Placebo: Conventional liquid bicarbonatedrug

Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking SFP at every dialysis session, for a total duration of 36 weeks.

Erythrocyte Stimulating Agent (ESA)drug

ESA was administered according to the recommendation of a blinded central anemia management center (CAMC) based on the weekly hemoglobin value and its rate of change.

Intravenous (IV) Irondrug

Approved IV iron preparations were administered per a protocol driven algorithm when patients serum ferritin value decreased below 200 ug/L.