Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout

Completed · Phase 2

Conditions studied: Gout

In brief

The purpose of this study is to determine whether PEG-uricase (a chemically modified recombinant mammalian enzyme that degrades uric acid) is effective in controlling hyperuricemia in patients with chronic gout, who cannot tolerate, or have not responded adequately, to conventional therapy for gout. Funding Source - FDA OOPD

Key facts

Study ID

NCT00111657

Run by

John Sundy

People needed

30

Starts

2004-12-01

Expected to finish

2009-07-01

Last updated by the study team

2014-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years
• Symptomatic gout
• Serum uric acid >7 mg/dL
• Intolerance of, or inadequate response to, conventional therapy for gout
• Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method

You may not qualify if…

• End stage renal failure that requires dialysis
• Concurrent use of uric-acid lowering agents
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• A history of anaphylactic reaction to a recombinant protein
• Concurrent use of immunosuppressive therapy (except as needed for prevention of rejection of a transplanted organ, or prednisone at 10 mg a day or less for treatment of gout flares)
• A medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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