Conditions: End Stage Renal Disease
Keywords: End Stage Renal Disease, Hemodialysis, SFP
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 108
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the clinical safety and efficacy of SFP in sparing the need for erythropoiesis stimulating agents (ESAs) required to maintain hemoglobin (hgb) levels in chronic hemodialysis subjects who receive SFP via the dialysate versus subjects who receive conventional dialysate without iron.

Detailed description:

Arms:
arm 1: None arm 2: Control concentrate lacking SFP does not contain SFP (total iron = 0)

Interventions: intervention 1: Soluble Ferric Pyrophosphate in liquid bicarbonate intervention 2: Placebo: Conventional liquid bicarbonate intervention 3: Erythrocyte Stimulating Agent (ESA) intervention 4: Intravenous (IV) Iron
Intervention descriptions: intervention 1: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks. intervention 2: Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking SFP at every dialysis session, for a total duration of 36 weeks. intervention 3: ESA was administered according to the recommendation of a blinded central anemia management center (CAMC) based on the weekly hemoglobin value and its rate of change. intervention 4: Approved IV iron preparations were administered per a protocol driven algorithm when patients serum ferritin value decreased below 200 ug/L.

Protocol document: