drugset / Trial / NCT02909153

Study of Intraperitoneal Triferic in Patients on Chronic Peritoneal Dialysis

NCT02909153

Phase 1 Completed 30 enrolled Rockwell Medical Technologies, Inc.
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2017-01
Primary completion
2017-07
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Triferic Other / unclassified 5 unknown Other
Subject Triferic Other / unclassified 6.6 mg Other
Subject Triferic Other / unclassified 12.5 unknown Other
Subject Triferic Other / unclassified 20 unknown Other