NCT02268994

KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD

A Phase 3 Study of KRX-0502 (Ferric Citrate) for the Treatment of Iron Deficiency Anemia (IDA) in Adult Subjects With Non-Dialysis Dependent (NDD) Chronic Kidney Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Keryx Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Anemia of Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	ferric citrate	1 g ferric citrate containing approximately 210 mg of ferric iron
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-10-20
• Last updated: 2018-03-22
• Results posted: 2018-02-22

Locations

36 sites across 1 country: United States