Conditions: End Stage Renal Disease
Keywords: pharmacokinetics bioequivalence
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 13
Healthy volunteers: no

Brief summary:
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via hemodialysate and via two different intravenous routes in adult patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study.

Detailed description:

Arms:
arm 1: Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic via the hemodialysate over the course of the dialysis treatment.

Intervention Drug: Triferic arm 2: Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via the unused heparin infusion line (pre-dialyzer).

Intervention: Drug: Triferic arm 3: Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via an infusion port (post-dialyzer).

Intervention: Drug: Triferic

Interventions: intervention 1: Triferic
Intervention descriptions: intervention 1: None

Protocol document: