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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
12
a single 8 mg iv (in the vein) dose before hemodialysis session
Davita Clinical Research
Minneapolis, Minnesota, United States
• 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
• To evaluate the pharmacodynamics (PD) of pegloticase and SUA, before and after hemodialysis sessions
Time frame: 1 month
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