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End Stage Renal Disease

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

Sponsored by Rockwell Medical Technologies, Inc.

About this trial

Last updated 4 years ago

Study ID

RMFPC-26

Status

Completed

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status