Status:
COMPLETED
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
Lead Sponsor:
Rockwell Medical Technologies, Inc.
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04042324
Start Date
September 30 2019
End Date
January 16 2020
Last Update
December 2 2020
Active Locations (1)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809