NCT01739660

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

A Phase 1, Single Site, Open-Label Study to Assess the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Savient Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Kidney Disease Stage 5

Interventions

Type	Name	Description
DRUG	Pegloticase	a single 8 mg iv (in the vein) dose before hemodialysis session

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-12-03
• Last updated: 2013-10-25

Locations

1 site across 1 country: United States