Triferic AVNU Infusion Via Freedom Pump During Hemodialysis

Phase 4

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: Triferic AVNU

• 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.

Study Timeline

• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-30
• Study Start: 2021-04-19
• Primary Completion: 2021-06-19
• Study Completion: 2021-06-19
• Results First Submitted: 2021-12-17
• Results First Submitted QC: 2021-12-17
• Results First Posted: 2022-01-18
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-15
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

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