Last updated on October 2018

Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function

Brief description of study

This is a randomized, double blind, active control study of PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients treated for approximately 1 year with agalsidase beta and on a stable dose for at least 6 months will be screened and then randomized to continue treatment with 1mg/kg agalsidase beta or to treatment with 1 mg/kg of PRX-102. The identity of the enzyme will be blinded to the patient and the investigator. Patients will receive intravenous infusions every two weeks. Patients will be randomized in a 2:1 ratio of PRX-102 to agalsidase beta. Randomization will be stratified by urinary protein to creatinine ratio (UPCR) of < or 1 g/g by spot urine sample. No more than 50% of the patients will be female.

Clinical Study Identifier: NCT02795676

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UAB Medicine

Birmingham, AL United States
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Infusion Associates

Grand Rapids, MI United States
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O+O Alpan LLC

Fairfax, VA United States
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University of Washington

Seattle, WA United States
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Medical College of Wisconsin

Milwaukee, WI United States
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UZ Antwerpen

Edegem, Belgium
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Addenbrooke's Hospital

Cambridge, United Kingdom
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Arkansas Children's hospital

Little Rock, AR United States
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Recruitment Status: Open

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