NCT03303144

Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Rockwell Medical Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The main purpose is to establish the equivalence of Triferic iron administered via dialysate into the arterial blood line and into the venous blood line

Detailed description

An open-label, four period, randomized, crossover study of Triferic iron administered via hemodialysis compared to Triferic administered intravenously pre- and post- hemodialyzer.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Triferic	ferric pyrophosphate citrate

Timeline

• Start date: 2017-10-01
• Primary completion: 2017-12-28
• Completion: 2017-12-28
• First posted: 2017-10-05
• Last updated: 2020-11-16
• Results posted: 2020-11-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study