Status:
COMPLETED
Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
Lead Sponsor:
Rockwell Medical Technologies, Inc.
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours
Detailed Description
An open-label, randomized, four period sequential study of Triferic AVNU administered intravenously by three different administration schedules compared to continuous infusion over 3 hours
Eligibility Criteria
Inclusion
- Adult hemodialysis patients ≥18 years of age.
- Signed informed consent to participate in the study.
- Stable on hemodialysis prescription for ≥3 months.
- Able to sustain hemodialysis 3x/week for 3 to 4 hours.
- Hemoglobin concentration \>9.5 g/dL.
- Serum TSAT ≥20%.
- Receiving hemodialysis via AV fistula or graft.
- Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.
- Able to receive intermittent heparin administration for anticoagulation of the dialysis circuit.
- Serum TIBC ≥ 150 µg/dL.
Exclusion
- Active bleeding disorder (GI, skin, nasal…)
- Receiving hemodialysis via catheter.
- Receiving IV iron within 10 days of the first on-study hemodialysis treatment.
- Receiving oral iron within 10 days of the first on-study hemodialysis treatment.
- Any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04409132
Start Date
June 25 2020
End Date
April 2 2021
Last Update
July 13 2021
Active Locations (1)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809