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

Rockwell Medical

Status and phase: Completed; Phase 2; Phase 1

Conditions: End Stage Renal Disease

Treatments: Drug: Triferic

Study type: Interventional

Funder types: Industry

Identifiers

NCT04409132

RMFPC-26

Details and patient eligibility

About

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

Full 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

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

23 participants in 4 patient groups

Triferic AVNU infusion pre-dialyzer

Experimental group

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.

Treatment:

Drug: Triferic

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

Experimental group

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.

Treatment:

Drug: Triferic

Triferic AVNU for injection at T=0

Experimental group

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.

Treatment:

Drug: Triferic

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

Experimental group

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.

Treatment:

Drug: Triferic