Conditions: Hyperphosphatemia Kidney Failure
Keywords: ESRD end-stage renal disease dialysis hemodialysis peritoneal dialysis hemodialysis (HD) peritoneal dialysis (PD) chronic renal insufficiency phosphate binder kidney failure renal failure
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 441
Healthy volunteers: no

Brief summary:
This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.

Detailed description:
This trial is a three-period, multicenter, safety and efficacy clinical trial. The first period is a two-week Washout Period, the second period is a 52-week randomized, open-label, active control Safety Assessment Period, and the third period is a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period in only the patients who were randomized to treatment with ferric citrate during the Safety Assessment Period. The primary objectives of this trial are to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with ESRD undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in the four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period.

Arms:
arm 1: PhosLo (calcium acetate) Renvela (sevelamer carbonate) arm 2: Placebo arm 3: ferric citrate

Interventions: intervention 1: ferric citrate, ca acetate, sevelamer carbonate, placebo
Intervention descriptions: intervention 1: All intervention doses will be based on serum phosphorus levels and/or drug label requirements

Protocol document: