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

NCT ID: NCT04042324

Last Updated: 2020-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2020-01-16

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 treatment is administered via separate routes.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triferic post-dialyzer; UFH via continuous infusion

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.

Group Type: EXPERIMENTAL

Triferic

Intervention Type: DRUG

Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.

Heparin

Intervention Type: DRUG

Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.

UFH and Triferic admixture

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.

Group Type: EXPERIMENTAL

Triferic

Intervention Type: DRUG

Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.

Heparin

Intervention Type: DRUG

Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.

UFH via continuous infusion pre-dialyzer

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

Group Type: EXPERIMENTAL

Heparin

Intervention Type: DRUG

Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.

Interventions

Triferic

Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.

Intervention Type: DRUG

Heparin

Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.

Intervention Type: DRUG

Other Intervention Names

ferric pyrophosphate citrate; FPC; Unfractionated heparin; UFH

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rockwell Medical Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond Pratt, MD

Role: STUDY_DIRECTOR

Rockwell Medical

Locations

Orlando Clinical Research Center

Orlando, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RMFPC-24

Identifier Type: -

Identifier Source: org_study_id