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

Rockwell Medical

Status and phase: Completed; Phase 2; Phase 1

Conditions: End Stage Renal Disease

Treatments: Drug: Triferic; Drug: Heparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04042324

RMFPC-24

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Triferic post-dialyzer; UFH via continuous infusion

Experimental group

Description:

Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis.

Treatment:

Drug: Heparin

Drug: Triferic

UFH and Triferic admixture

Experimental group

Description:

Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis.

Treatment:

Drug: Heparin

Drug: Triferic

UFH via continuous infusion pre-dialyzer

Experimental group

Description:

Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis

Treatment:

Drug: Heparin