Triferic AVNU Infusion Via Freedom Pump During Hemodialysis

NCT04689932 | Completed Phase 4 Results FDA Drug

• 1 other identifier: RMFPC-ISS002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (2)

• Mean TSAT Max Pre-Dialyzer

  up to 3 hours

• Mean TSAT Max Post-Dialyzer

  up to 3 hours

Study Arms (1)

Pre- Dialyzer Infusion and Post- Dialyzer Infusion

EXPERIMENTAL

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.

Drug: Triferic AVNU

Interventions

Triferic AVNU DRUG

Ferric Pyrophosphate Citrate

Also known as: FPC

Pre- Dialyzer Infusion and Post- Dialyzer Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hemodynamically unstable during hemodialysis
• Evidence of active bleeding from the GI tract.

Sponsors & Collaborators

• Rockwell Medical Technologies, Inc.: lead

Study Sites (1)

Luxury Dialysis

Webster, Texas, 77598, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Raymond D Pratt, MD
• Organization: Rockwell Medical

rpratt@rockwellmed.com

2489609009

Study Officials

• Raymond D Pratt, MD, FACP

  Rockwell Medical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 30, 2020
• Study Start: April 19, 2021
• Primary Completion: June 19, 2021
• Study Completion: June 19, 2021
• Last Updated: February 28, 2022
• Results First Posted: January 18, 2022

Record last verified: 2022-02

Locations

US (1)