Conditions: Renal Failure Chronic Requiring Hemodialysis
Keywords: End Stage Renal Disease Hemodialysis SFP Hemodialysis-dependent chronic renal failure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 305
Healthy volunteers: no

Brief summary:
The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the change from baseline in hemoglobin (Hgb).

Detailed description:
Screening: 2-3 weeks prior to enrollment in Stage 1.

Stage 1 (Run-In): 1-4 weeks depending on qualification for Stage 2.

Stage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely.

Stage 3 (Open-Label Treatment): The duration of Stage 2 plus Stage 3 is intended to be 18 months regardless of treatment assignment in Stage 2.

Arms:
arm 1: 11 micrograms (µg) of iron / deciliter (dL) of dialysate. arm 2: 0 micrograms (µg) of iron / deciliter (dL) of dialysate.

Interventions: intervention 1: Soluble Ferric Pyrophosphate (SFP) intervention 2: Standard dialysate
Intervention descriptions: intervention 1: Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months. intervention 2: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.

Protocol document: