NCT04042324

A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

A Randomized 3 Period Crossover Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Rockwell Medical Technologies, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the effect of co-administration of Triferic and heparin on the ability to maintain circuit anti-coagulation and iron delivery when compared to control conditions when each treatment is administered via separate routes.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Triferic	Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
DRUG	Heparin	Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.

Timeline

• Start date: 2019-09-30
• Primary completion: 2020-01-16
• Completion: 2020-01-16
• First posted: 2019-08-01
• Last updated: 2020-12-02
• Results posted: 2020-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study