Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
- Registration Number
- NCT04689932
- Lead Sponsor
- Rockwell Medical Technologies, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- 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.
- Hemodynamically unstable during hemodialysis
- Evidence of active bleeding from the GI tract.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Pre- Dialyzer Infusion and Post- Dialyzer Infusion Triferic AVNU 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.
- Primary Outcome Measures
Name Time Method Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer 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 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 Outcome Measures
Name Time Method Mean TSAT Max Post-Dialyzer up to 3 hours The maximum Transferrin saturation (TSATmax) for the infusion of FPC into the pre-dialyzer blood line when compared to the TSATmax when FPC is infused into the post-dialyzer blood line is an index of any loss of FPC during transit through the dialyzer (artificial kidney
Mean TSAT Max Pre-Dialyzer up to 3 hours The maximum Transferrin saturation (TSATmax) for the infusion of FPC into the pre-dialyzer blood line when compared to the TSATmax when FPC is infused into the post-dialyzer blood line is an index of any loss of FPC during transit through the dialyzer (artificial kidney
Trial Locations
- Locations (1)
Luxury Dialysis
🇺🇸Webster, Texas, United States