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

NCT ID: NCT04409132

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2021-04-02

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

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triferic AVNU infusion pre-dialyzer

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

Group Type: EXPERIMENTAL

Triferic

Intervention Type: DRUG

Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.

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

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.

Group Type: EXPERIMENTAL

Triferic

Intervention Type: DRUG

Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.

Triferic AVNU for injection at T=0

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.

Group Type: EXPERIMENTAL

Triferic

Intervention Type: DRUG

Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.

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

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.

Group Type: EXPERIMENTAL

Triferic

Intervention Type: DRUG

Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.

Interventions

Triferic

Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.

Intervention Type: DRUG

Other Intervention Names

ferric pyrophosphate citrate; FPC

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rockwell Medical Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond D Pratt, MD, FACP

Role: STUDY_DIRECTOR

Rockwell Medical

Locations

Orlando Clinical Research Center

Orlando, Florida, United States

Countries

United States

Other Identifiers

RMFPC-26

Identifier Type: -

Identifier Source: org_study_id