A 58-Week Safety and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-stage Renal Disease (ESRD) on Dialysis

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.