Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
End Stage Renal Disease
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Pharmacokinetics
Eligibility 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.
Sites / Locations
- Orlando Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Triferic AVNU infusion pre-dialyzer
Triferic AVNU for injection at T=0 and T= 3 hours
Triferic AVNU for injection at T=0
Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours
Patients will receive one (1) 6.75 mg Fe dose of Triferic AVNU by continuous infusion over 3 hours into the predialyzer blood line.
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.
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.
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.