Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Sponsored by Rockwell Medical Technologies, Inc.
About this trial
Last updated 3 years ago
Study ID
RMFPC-ISS002
Status
Completed
Type
Interventional
Phase
Phase 4
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 4 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
1. Participant must be 18 years of age inclusive, at the time of signing the informed consent.
2. Receiving chronic hemodialysis for 3-4 hours each session 3x/week.
3. Medically stable according to the investigator opinion
4. 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 Criteria
1. Hemodynamically unstable during hemodialysis
2. Evidence of active bleeding from the GI tract.