Status:
COMPLETED
Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Lead Sponsor:
Rockwell Medical Technologies, Inc.
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main purpose of this study is to evaluate the delivery of Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood lines.
Detailed Description
This is a single center, multi dose, open label study assessing the delivery of Triferic AVNU administered intravenously to adult patients (\> or equal to 18 years of age) using the Freedom Pump-20 du...
Eligibility Criteria
Inclusion
- Participant must be 18 years of age inclusive, at the time of signing the informed consent.
- Receiving chronic hemodialysis for 3-4 hours each session 3x/week.
- Medically stable according to the investigator opinion
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion
- Hemodynamically unstable during hemodialysis
- Evidence of active bleeding from the GI tract.
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04689932
Start Date
April 19 2021
End Date
June 19 2021
Last Update
February 28 2022
Active Locations (1)
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1
Luxury Dialysis
Webster, Texas, United States, 77598