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Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Triferic
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 focused on measuring Pharmacokinetics

Eligibility Criteria

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

Inclusion Criteria:

  • Adult hemodialysis patients ≥18 years of age.
  • Signed informed consent to participate in the study.
  • Stable on hemodialysis prescription for ≥3 months.
  • Able to sustain hemodialysis 3x/week for 3 to 4 hours.
  • Hemoglobin concentration >9.5 g/dL.
  • Serum TSAT ≥20%.
  • Receiving hemodialysis via AV fistula or graft.
  • Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.
  • Able to receive intermittent heparin administration for anticoagulation of the dialysis circuit.
  • Serum TIBC ≥ 150 µg/dL.

Exclusion Criteria:

  • Active bleeding disorder (GI, skin, nasal…)
  • Receiving hemodialysis via catheter.
  • Receiving IV iron within 10 days of the first on-study hemodialysis treatment.
  • Receiving oral iron within 10 days of the first on-study hemodialysis treatment.
  • Any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.

Sites / Locations

  • Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Triferic AVNU infusion pre-dialyzer

Triferic AVNU for injection at T=0 and T= 3 hours

Triferic AVNU for injection at T=0

Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours

Arm Description

Patients will receive one (1) 6.75 mg Fe dose of Triferic AVNU by continuous infusion over 3 hours into the predialyzer blood line.

Patients will receive two (2) doses of Triferic AVNU 3.4 mg IV (2.25 mL) at T=0 and T=3 hours of hemodialysis into the venous drip chamber.

Patients will receive one (1) dose of Triferic AVNU 0.08 mg/kg IV, up to 6.75 mg Fe, at T=0 of hemodialysis into the venous drip chamber.

Patients will receive three (3) doses of Triferic AVNU 2.25 mg Fe (1.5 mL) at T=0, T=1.5 and T=3.0 hours of hemodialysis into the venous drip chamber.

Outcomes

Primary Outcome Measures

Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D
Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D

Secondary Outcome Measures

Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D
Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D
Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D
Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D

Full Information

First Posted
May 26, 2020
Last Updated
July 12, 2021
Sponsor
Rockwell Medical Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04409132
Brief Title
Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
Official Title
A Randomized 4 Period Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
April 2, 2021 (Actual)
Study Completion Date
April 2, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours
Detailed Description
An open-label, randomized, four period sequential study of Triferic AVNU administered intravenously by three different administration schedules compared to continuous infusion over 3 hours

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triferic AVNU infusion pre-dialyzer
Arm Type
Experimental
Arm Description
Patients will receive one (1) 6.75 mg Fe dose of Triferic AVNU by continuous infusion over 3 hours into the predialyzer blood line.
Arm Title
Triferic AVNU for injection at T=0 and T= 3 hours
Arm Type
Experimental
Arm Description
Patients will receive two (2) doses of Triferic AVNU 3.4 mg IV (2.25 mL) at T=0 and T=3 hours of hemodialysis into the venous drip chamber.
Arm Title
Triferic AVNU for injection at T=0
Arm Type
Experimental
Arm Description
Patients will receive one (1) dose of Triferic AVNU 0.08 mg/kg IV, up to 6.75 mg Fe, at T=0 of hemodialysis into the venous drip chamber.
Arm Title
Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours
Arm Type
Experimental
Arm Description
Patients will receive three (3) doses of Triferic AVNU 2.25 mg Fe (1.5 mL) at T=0, T=1.5 and T=3.0 hours of hemodialysis into the venous drip chamber.
Intervention Type
Drug
Intervention Name(s)
Triferic
Other Intervention Name(s)
ferric pyrophosphate citrate, FPC
Intervention Description
Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
Primary Outcome Measure Information:
Title
Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D
Time Frame
8 hours
Title
Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D
Time Frame
8 hours
Title
Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D
Time Frame
8 hours
Title
Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D
Time Frame
8 hours
Title
Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult hemodialysis patients ≥18 years of age. Signed informed consent to participate in the study. Stable on hemodialysis prescription for ≥3 months. Able to sustain hemodialysis 3x/week for 3 to 4 hours. Hemoglobin concentration >9.5 g/dL. Serum TSAT ≥20%. Receiving hemodialysis via AV fistula or graft. Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods. Able to receive intermittent heparin administration for anticoagulation of the dialysis circuit. Serum TIBC ≥ 150 µg/dL. Exclusion Criteria: Active bleeding disorder (GI, skin, nasal…) Receiving hemodialysis via catheter. Receiving IV iron within 10 days of the first on-study hemodialysis treatment. Receiving oral iron within 10 days of the first on-study hemodialysis treatment. Any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.
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
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.

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