Trial Outcomes & Findings for Triferic AVNU Infusion Via Freedom Pump During Hemodialysis (NCT NCT04689932)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

On Days 1, 3, and 5, up to 3 hours

Results posted on

2022-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	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. Triferic AVNU: Ferric Pyrophosphate Citrate
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Triferic AVNU Infusion Via Freedom Pump During Hemodialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pre- Dialyzer Infusion and Post- Dialyzer Infusion n=12 Participants 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. Triferic AVNU: Ferric Pyrophosphate Citrate
Age, Continuous	62.5 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pre- Dialyzer Infusion and Post- Dialyzer Infusion n=12 Participants 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. Triferic AVNU: Ferric Pyrophosphate Citrate
Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer	1.7 hours Standard Deviation 2.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Pre- Dialyzer Infusion and Post- Dialyzer Infusion n=12 Participants 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. Triferic AVNU: Ferric Pyrophosphate Citrate
Time for Complete Infusion of 4.5 mL Triferic AVNU Post-Dialyzer	2.5 hours Standard Deviation 2.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Pre- Dialyzer Infusion and Post- Dialyzer Infusion n=12 Participants 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. Triferic AVNU: Ferric Pyrophosphate Citrate
Mean TSAT Max Pre-Dialyzer	88 percentage of saturation Standard Deviation 101

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Pre- Dialyzer Infusion and Post- Dialyzer Infusion n=12 Participants 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. Triferic AVNU: Ferric Pyrophosphate Citrate
Mean TSAT Max Post-Dialyzer	67 percentage of saturation Standard Deviation 81

Adverse Events

Pre- Dialyzer Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Post- Dialyzer Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Raymond D Pratt, MD

Rockwell Medical

Phone: 2489609009

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60