Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer
Study Overview
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 during hemodialysis into the pre-dialyzer and post-dialyzer blood lines.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Pre- Dialyzer Infusion and Post- Dialyzer Infusion
On study day 1, day 3 and day 5, patients will receive 6.75 mg Fe/4.5 mL Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the pre-dialyzer blood line. On study day 2, day 4 and day 6, patients will receive the 6.75 mg Fe/4.5 mL Triferic AVNU intravenously using the Freedom Pump-20 during hemodialysis into the post dialysis blood line.
Intervention: Triferic AVNU (Drug)
Outcomes
Primary Outcomes
Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer
Time Frame: On Days 1, 3, and 5, up to 3 hours
The syringe pump and flow restrictor tubing has a nominal flow rate of 2 mL/hour. When the tubing is connected to the pre-dialyzer or post dialyzer blood circuit the administration time will vary due to the pressure in the dialyzer blood lines. For a 4.5 mL volume the target administration rate is 2.25 hours. The Product labeling for Triferic AVNU advises the dose (4.5 mL) to be administered over 3 to 4 hours.
Time for Complete Infusion of 4.5 mL Triferic AVNU Post-Dialyzer
Time Frame: On Days 2, 4, and 6, up to 3 hours
The syringe pump and flow restrictor tubing has a nominal flow rate of 2 mL/hour. When the tubing is connected to the pre-dialyzer or post dialyzer blood circuit the administration time will vary due to the pressure in the dialyzer blood lines. For a 4.5 mL volume the target administration rate is 2.25 hours. The Product labeling for Triferic AVNU advises the dose (4.5 mL) to be administered over 3 to 4 hours.
Secondary Outcomes
- Mean TSAT Max Post-Dialyzer(up to 3 hours)
- Mean TSAT Max Pre-Dialyzer(up to 3 hours)