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

NCT04409132 | Completed Phase 1 FDA Drug

• 1 other identifier: RMFPC-26
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

End Stage Renal Disease

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (4)

Triferic AVNU infusion pre-dialyzer

EXPERIMENTAL

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

EXPERIMENTAL

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 AVNU for injection at T=0

EXPERIMENTAL

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

EXPERIMENTAL

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

Interventions

Triferic DRUG

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

Also known as: ferric pyrophosphate citrate, FPC

Triferic AVNU for injection at T=0; Triferic AVNU for injection at T=0 and T= 3 hours; Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours; Triferic AVNU infusion pre-dialyzer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rockwell Medical Technologies, Inc.: lead

Study Sites (1)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

ferric pyrophosphate; spleen fibrinolytic proteinase (human)

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raymond D Pratt, MD, FACP

  Rockwell Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 1, 2020
• Study Start: June 25, 2020
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)