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Clinical trial

A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

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Last updated:1st Oct 2010

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.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Three-Period, 58-Week Safety and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis
Enrollment: 441
Study Start Date: October 2010
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Arms:
- Active Comparator:
Active Control
- Placebo Comparator: Placebo
- Experimental: KRX-0502 (Ferric Citrate)

Category Value
Study start date 2010-10-01

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