Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
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.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase 1, Single Site, Open-Label Study to Assess the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis|
- • To evaluate the pharmacokinetics (PK) of pegloticase after a single-dose administration to hemodialysis patients when administered starting 3 hours before dialysis [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- • To evaluate the pharmacodynamics (PD) of pegloticase and SUA, before and after hemodialysis sessions [ Time Frame: 1 month ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Pegloticase 8 mg single intraveneous dose
a single 8 mg iv (in the vein) dose before hemodialysis session
Other Name: KRYSTEXXA
End stage renal disease (ESRD) patients that require hemodialysis typically undergo hemodialysis treatment 3 times per week. As such, medications can be dialyzed off, reducing their clinical effectiveness; this study is being conducted to understand how dialysis affects the pharmacokinetics (PK) and pharmacodynamics (PD) of pegloticase.
|United States, Minnesota|
|Davita Clinical Research|
|Minneapolis, Minnesota, United States, 55404|
|Principal Investigator:||Harry Alcorn, Pharm D||Davita Clinical Research|