CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Trifericdrug
Likely dose
Not stated in 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/NCT02909153
NCT02909153Phase 1Completed
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Single Ascending Dose Study of Intraperitoneal Triferic (Ferric Pyrophosphate Citrate) in Patients on Chronic Peritoneal Dialysis

Rockwell Medical Technologies, Inc.·interventional·Posted Sep 21, 2016·Updated Aug 8, 2019

In Brief

A Phase 1 clinical trial evaluating Triferic for Peritoneal Dialysis (PD) and 2 related conditions. Completed, enrolled 30 participants.

Detailed Summary

The main purpose is to determine the pharmacokinetic (PK) profile, maximum concentration (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). It is an open label, dose escalation study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeritoneal Dialysis (PD), Anemia, Chronic Kidney Disease
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 21, 2016
Enrollment StartJan 1, 2017
Primary CompletionJul 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.8 years ago

Interventions

Trifericdrug

Triferic is an iron salt that is approved by the FDA for the maintenance of hemoglobin in patients with end stage kidney disease on hemodialysis. It is experimental in this study because it has not yet been approved for patients on chronic peritoneal dialysis.