Ferric Citrate in Patients With End-Stage Renal Disease on Dialysis

Status Completed

Clinical Trial Summary

The main purpose of this study is to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with end-stage renal disease undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period. Main eligibility criteria Males or non-pregnant, non-breast-feeding females, age 18 years, on thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening Visit (Visit 0), Serum phosphorus levels greater than or equal to 2.5 mg/dL and less than or equal to 8.0 mg/dL at Screening Visit (Visit 0), Serum phosphorus greater than or equal to 6.0 mg/dL during the Washout Period (Visits 2 or 3), taking 3 to 18 pills/day of calcium acetate, calcium carbonate, lanthanum carbonate, and/or sevelamer (carbonate or hydrochloride or equivalent sevelamer powder) or any other agent serving as a phosphate binder, or any combination and serum ferritin less than 1000 micrograms/L and less than TSAT 50% at the Screening Visit (Visit 0).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01510106
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Completed
Phase	Phase 3
Start date	April 2011
Completion date	March 2013

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See also
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