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Completed

NCT Number: NCT04689932

Triferic AVNU Infusion Via Freedom Pump During Hemodialysis

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Luxury Dialysis

Webster, Texas, 77598, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triferic AVNU

Drug

Ferric Pyrophosphate Citrate

Other names: FPC

Primary outcomes

  1. 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.

  2. 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

  1. Mean TSAT Max Pre-Dialyzer

    Time frame: 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

  2. Mean TSAT Max Post-Dialyzer

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rockwell Medical Technologies, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2020
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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