Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
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|ClinicalTrials.gov Identifier: NCT01739660|
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : October 25, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Stage 5||Drug: Pegloticase||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Pegloticase 8 mg single intraveneous dose
a single 8 mg iv (in the vein) dose before hemodialysis session
Other Name: KRYSTEXXA
- • 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739660
|United States, Minnesota|
|Davita Clinical Research|
|Minneapolis, Minnesota, United States, 55404|
|Principal Investigator:||Harry Alcorn, Pharm D||Davita Clinical Research|