Triferic AVNU Infusion Via Freedom Pump During Hemodialysis

• Status: Completed
• Trial end date: 2021-06-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rockwell Medical Technologies, Inc.

Criteria

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.