Triferic AVNU Infusion Via Freedom Pump During Hemodialysis

End Stage Renal Disease Clinical Trial

Official title:

Triferic AVNU Infusion Via Freedom Pump During Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689932
• Other study ID #: RMFPC-ISS002
• Status: Completed
• Phase: Phase 4
• Start date: April 19, 2021
• Est. completion date: June 19, 2021

Study information

• Verified date: February 2022
• Source: Rockwell Medical Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 19, 2021
• Est. primary completion date: June 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Triferic AVNU
Ferric Pyrophosphate Citrate

Locations

Country	Name	City	State
United States	Luxury Dialysis	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Rockwell Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	up to 3 hours
Secondary	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	up to 3 hours