Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis

Summary

This is a Phase 1 single dose study conducted to evaluate the PK and PD of pegloticase administered to hemodialysis patients. A single dose of pegloticase will be administered intravenously to male or female hemodialysis patients (N = 12) starting 3 hour prior to dialysis. The study consists of a Screening Period, a Treatment Period, and Follow up Period.

Timeline

Start

2012-12

Primary completion

2013-04

Completion

2013-04

Drugs

Indications