Conditions: End-Stage Renal Disease (ESRD)
Keywords: Subjects with ESRD receiving chronic Hemodialysis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 131
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis.

Detailed description:
The study was designed to evaluate the efficacy of SFP-containing dialysate solution in maintaining physiological iron levels during chronic hemodialysis, as measured by the primary endpoint of the percent of patients whose Hemoglobin (Hgb) decreased by at least 1.0 gram/ deciliter (g/dL) from baseline. The efficacy and safety findings are to be used to determine the optimal concentration of SFP needed to safely maintain iron levels, compensating for iron losses during chronic hemodialysis.

Arms:
arm 1: Placebo 0 micrograms (µg) of iron/ deciliter (dL) of dialysate arm 2: 5 micrograms (µg) of iron/ deciliter (dL) of dialysate arm 3: 10 micrograms (µg) of iron/ deciliter (dL) of dialysate arm 4: 12 micrograms (µg) of iron/ deciliter (dL) of dialysate arm 5: 15 micrograms (µg) of iron/ deciliter (dL) of dialysate

Interventions: intervention 1: Standard Bicarbonate Solution intervention 2: Soluble Ferric Pyrophosphate intervention 3: Soluble Ferric Pyrophosphate intervention 4: Soluble Ferric Pyrophosphate intervention 5: Soluble Ferric Pyrophosphate
Intervention descriptions: intervention 1: Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. intervention 2: Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. intervention 3: Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. intervention 4: Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks. intervention 5: Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.

Protocol document: