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Triferic AVNU Infusion Via Freedom Pump During Hemodialysis

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Triferic AVNU
Sponsored by
Rockwell Medical Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Luxury Dialysis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pre- Dialyzer Infusion and Post- Dialyzer Infusion

Arm Description

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.

Outcomes

Primary Outcome Measures

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 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.

Secondary Outcome Measures

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
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

Full Information

First Posted
December 28, 2020
Last Updated
February 15, 2022
Sponsor
Rockwell Medical Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04689932
Brief Title
Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Official Title
Triferic AVNU Infusion Via Freedom Pump During Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
June 19, 2021 (Actual)
Study Completion Date
June 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rockwell Medical Technologies, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre- Dialyzer Infusion and Post- Dialyzer Infusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Triferic AVNU
Other Intervention Name(s)
FPC
Intervention Description
Ferric Pyrophosphate Citrate
Primary Outcome Measure Information:
Title
Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer
Description
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
Title
Time for Complete Infusion of 4.5 mL Triferic AVNU Post-Dialyzer
Description
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 Outcome Measure Information:
Title
Mean TSAT Max Pre-Dialyzer
Description
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
Title
Mean TSAT Max Post-Dialyzer
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond D Pratt, MD, FACP
Organizational Affiliation
Rockwell Medical
Official's Role
Study Director
Facility Information:
Facility Name
Luxury Dialysis
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States

12. IPD Sharing Statement

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Triferic AVNU Infusion Via Freedom Pump During Hemodialysis

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