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

R

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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