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

Completed · Phase 1/Phase 2

Conditions studied: End Stage Renal Disease

In brief

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

Key facts

Study ID

NCT04409132

Run by

Rockwell Medical Technologies, Inc.

People needed

23

Starts

2020-06-25

Expected to finish

2021-04-02

Last updated by the study team

2021-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.