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

Completed · Phase 1/Phase 2

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT04042324

Run by

Rockwell Medical Technologies, Inc.

People needed

12

Starts

2019-09-30

Expected to finish

2020-01-16

Last updated by the study team

2020-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult hemodialysis patients ≥18 years of age.
• Signed informed consent to participate in the study.
• Stable on hemodialysis prescription for ≥3 months.
• Hemoglobin concentration >9.5 g/dL.
• Serum TSAT ≥20%.
• Able to receive continuous heparin infusion as their anticoagulation protocol.
• Receiving hemodialysis via AV (arteriovenous) fistula or graft.
• Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.

You may not qualify if…

• Active bleeding disorder (GI, skin, nasal…)
• Receiving hemodialysis via catheter.
• Receiving heparin free dialysis.
• Receiving low molecular weight heparin as sole anti-coagulation for dialysis.
• Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment.
• Receiving oral anti-coagulants or anti-platelet agents.
• Any other condition, that in the opinion of the investigator would not allow completion of the 3 hemodialysis treatments in the study.

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.