Back to resultsA Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Triferic
Heparin
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility Criteria
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.
Sites / Locations
- Orlando Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Triferic post-dialyzer; UFH via continuous infusion
UFH and Triferic admixture
UFH via continuous infusion pre-dialyzer
Arm 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.
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.
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
Outcomes
Primary Outcome Measures
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t
Secondary Outcome Measures
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours
aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)
Iron Profile as Measured by the AUC (Area Under the Curve) 0-t
Full Information
NCT ID
NCT04042324
First Posted
July 22, 2019
Last Updated
November 17, 2020
Sponsor
Rockwell Medical Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04042324
Brief Title
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
January 16, 2020 (Actual)
Study Completion Date
January 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rockwell Medical Technologies, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triferic post-dialyzer; UFH via continuous infusion
Arm Type
Experimental
Arm 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.
Arm Title
UFH and Triferic admixture
Arm Type
Experimental
Arm 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.
Arm Title
UFH via continuous infusion pre-dialyzer
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Triferic
Other Intervention Name(s)
ferric pyrophosphate citrate, FPC
Intervention Description
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
Intervention Name(s)
Heparin
Other Intervention Name(s)
Unfractionated heparin, UFH
Intervention Description
Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
Primary Outcome Measure Information:
Title
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time Frame
4 hours
Title
aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time Frame
4 hours
Title
TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time Frame
4 hours
Title
Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)
Time Frame
8 hours
Title
Iron Profile as Measured by the AUC (Area Under the Curve) 0-t
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Pratt, MD
Organizational Affiliation
Rockwell Medical
Official's Role
Study Director
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
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