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.

Sponsors

Lead Sponsor: Rockwell Medical Technologies, Inc.

Source Rockwell Medical Technologies, Inc.
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

Overall Status Recruiting
Start Date June 25, 2020
Completion Date December 20, 2020
Primary Completion Date December 20, 2020
Phase Phase 1/Phase 2
Study Type Interventional
Primary 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
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
Enrollment 12
Condition
Intervention

Intervention Type: Drug

Intervention Name: Triferic

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

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Raymond D Pratt, MD, FACP Study Director Rockwell Medical
Overall Contact

Last Name: Terrilyn Sharpe, MSHS

Phone: 248-819-3088

Email: [email protected]

Location
Facility: Status: Contact: Orlando Clinical Research Center Thomas Marbury, MD 407-472-0273 [email protected]
Location Countries

United States

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Triferic AVNU infusion pre-dialyzer

Type: Experimental

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.

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

Type: Experimental

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.

Label: Triferic AVNU for injection at T=0

Type: Experimental

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.

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

Type: Experimental

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov