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

A Randomized 4 Period Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.

This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Drug: Triferic

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

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Triferic; Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.; Other Names: FPC; ferric pyrophosphate citrate
Experimental: 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.	Drug: Triferic; Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.; Other Names: FPC; ferric pyrophosphate citrate
Experimental: 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.	Drug: Triferic; Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.; Other Names: FPC; ferric pyrophosphate citrate
Experimental: 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.	Drug: Triferic; Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.; Other Names: FPC; ferric pyrophosphate citrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D	8 hours
Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D	8 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D	8 hours
Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D	8 hours
Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D	8 hours
Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D	8 hours

Collaborators and Investigators

• Sponsor: Rockwell Medical Technologies, Inc.
• Investigators: Study Director: Raymond D Pratt, MD, FACP, Rockwell Medical

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Actual): April 2, 2021
• Study Completion (Actual): April 2, 2021

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Pharmacokinetics
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: RMFPC-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No