Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
Completed
Savient Pharmaceuticals
Phase 1
2012-12-01
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.
Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect
Completed
IND 2 Results LLC
Phase 2
2015-12-01
The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of
pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in patients
with chronic, refractory gout.
Tolerization Reduces Intolerance to Pegloticase and Prolongs the Urate Lowering Effect
Completed
Ampel BioSolutions, LLC
Phase 2
2015-12-01
The purpose of this study is to evaluate the effect of a high zone tolerizing regimen of
pegloticase on clinical outcome, as defined by an serum uric acid level <6 mg/dL, in patients
with chronic, refractory gout.
REduCing Immunogenicity to PegloticasE (RECIPE) Study
Completed
University of Michigan
Phase 2
2018-06-14
Pegloticase treatment for chronic refractory gout is limited by immunogenicity. The
investigators propose the REduCing Immunogenicity to PegloticasE (RECIPE) trial to begin to
investigate the question of whether a short course of immune modulating therapy with
mycophenolate mofetil can significantly and safely attenuate immunogenicity to pegloticase
and ensure patients afflicted with chronic refractory gout have better treatment outcomes and
improved quality of life.
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