Conditions: Anemia of Chronic Kidney Disease
Keywords: ferric citrate Chronic kidney disease Anemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 234
Healthy volunteers: no

Brief summary:
a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period").

Detailed description:
a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period"). The study will consist of 14 clinic visits over a period of 24 weeks. There will be a screening period of up to 14 days; Approximately 230 subjects will be randomized into the Randomized Period in a 1:1 ratio to receive either KRX-0502 or matching placebo, at baseline

Arms:
arm 1: 1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron arm 2: Matching Placebo

Interventions: intervention 1: ferric citrate intervention 2: Placebo
Intervention descriptions: intervention 1: 1 g ferric citrate containing approximately 210 mg of ferric iron intervention 2: Matching placebo

Protocol document: