A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Definitive Phase III Study of the Effects of Ferric Citrate on Serum Phosphate in Subjects With End Stage Renal Disease

The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).

Inclusion Criteria:

• Age>18 years and has a diagnosis of ESRD
• On a three-times per week hemodialysis regimen
• On a stable dose of a phosphate-binding agent for at least one month prior to study entry.
• If on vitamin D supplementation or calcitriol, must be on a stable dose for at least one month prior to study entry.
• Hct >= 20%
• Serum Ca level of 8 mg/dL to 10.5 mg/dL

Exclusion Criteria:

• Is pregnant or lactating
• Clinically significant GI disorder
• Has tertiary hyperparathyroidism or is immediately post-operative from a parathyroidectomy (within the first 3 months post-op or the plasma Ca is <7 mg/dL)
• ferritin>800 ng/mL
• Unstable medical condition unsuitable for the study in the opinion of investigator
• Has been treated with an investigational agent within 30 days of enrollment
• Has a history of documented iron allergy or hemochromatosis