NCT04689932 - Triferic AVNU Infusion Via Freedom Pump During Hemodialysis | Crick

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

12

Conditions

End Stage Renal Disease

Interventions

Triferic AVNUDRUG

Ferric Pyrophosphate Citrate

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Luxury Dialysis

Webster, Texas, United States

Outcomes

Primary Outcomes

Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer

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

Time for Complete Infusion of 4.5 mL Triferic AVNU Post-Dialyzer

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 frame: On Days 2, 4, and 6, up to 3 hours

Secondary Outcomes

Mean TSAT Max Pre-Dialyzer

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

Time frame: up to 3 hours

Mean TSAT Max Post-Dialyzer

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

Time frame: up to 3 hours