Conditions: End Stage Renal Disease Kidney Failure Renal Failure Hyperphosphatemia ESRD
Keywords: Participation Limited Long Term Safety Extension
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 168
Healthy volunteers: no

Brief summary:
A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.

Detailed description:
This study was an open-label, 48-week safety extension of Study KRX-0502-304 (Study 304), to evaluate the safety of long-term use of KRX-0502 in subjects with ESRD for up to 2 years of cumulative exposure. Subjects who completed the Safety Assessment Period (SAP) and, if eligible, the Efficacy Assessment Period (EAP) of Study 304, independent of their assigned treatment arm in the SAP or EAP of Study 304, were eligible for participation in this long-term safety extension study. No new subjects were permitted to enter this study.

Arms:
arm 1: Open label extension of those completing study KRX-0304

Interventions: intervention 1: ferric citrate
Intervention descriptions: intervention 1: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.

Protocol document: