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

• Status: Completed
• Trial end date: 2021-04-02
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rockwell Medical Technologies, Inc.

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.