- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04042324
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
Conditions
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:
- 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 Criteria:
- 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.
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:
Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Other Names:
|
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:
Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Other Names:
|
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:
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMFPC-24
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.
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