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

November 17, 2020 updated by: Rockwell Medical Technologies, Inc.

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
Other Names:
  • FPC
  • ferric pyrophosphate citrate
Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Other Names:
  • Unfractionated heparin
  • UFH
Experimental: 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.
Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
Other Names:
  • FPC
  • ferric pyrophosphate citrate
Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Other Names:
  • Unfractionated heparin
  • UFH
Experimental: 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
Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Other Names:
  • Unfractionated heparin
  • UFH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t
Time Frame: 8 hours
8 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time Frame: 4 hours
4 hours
aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time Frame: 4 hours
4 hours
TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time Frame: 4 hours
4 hours
Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)
Time Frame: 8 hours
8 hours
Iron Profile as Measured by the AUC (Area Under the Curve) 0-t
Time Frame: 8 hours
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Raymond Pratt, MD, Rockwell Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Actual)

January 16, 2020

Study Completion (Actual)

January 16, 2020

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

December 2, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease

Clinical Trials on Triferic

3
Subscribe