Phase 4
Completed N=12
Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Source: ClinicalTrials.gov NCT04689932 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer — 1.7 hours
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer |
1.7 | — |
| PRIMARY Time for Complete Infusion of 4.5 mL Triferic AVNU Post-Dialyzer |
2.5 | — |
| SECONDARY Mean TSAT Max Pre-Dialyzer |
88 | — |
| SECONDARY Mean TSAT Max Post-Dialyzer |
67 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Hemodynamically unstable during hemodialysis
- Evidence of active bleeding from the GI tract.
Data sourced from ClinicalTrials.gov (NCT04689932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.