Last updated on September 2017

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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Eric L Wallace, MD

UAB Medicine
Birmingham, AL United States
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Anjay Rastogi

University of California Los Angeles
Los Angeles, CA United States
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Virginia Kimonis

University of California Irvine Center
Orange, CA United States
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Madelena Martin

University of California Davis Health System
Sacramento, CA United States
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Bruce Barshop

University of California San Diego
San Diego, CA United States
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William Wilcox, MD

Emory University School of Medicine
Atlanta, GA United States
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Bernat John, MD

University of Iowa Hosptials and Clinics
Iowa City, IA United States
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Amel Karaa

Massachusetts General Hospital
Boston, MA United States
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Kahn Nedd, MD

Infusion Associates
Grand Rapids, MI United States
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Chester Whitley

Regents of the University of Minnesota
Minneapolis, MN United States
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Heather Lau, MD

New York University Medical Center
New York, NY United States
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Marie McDonald

Duke University Medical Center
Durham, NC United States
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Robert Hopkin, MD

Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States
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Gerard Vockley, Md, PhD

Children's Hospital of Pittsburgh
Pittsburgh, PA United States
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Raphael Schiffmann, MD, MHSc

Institute of Metabolic Disease, Baylor Healthcare
Dallas, TX United States
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Nicola Longo, MD, PhD

Eccles Primary Children's Outpatient Services Building
Salt Lake City, UT United States
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Ozlem Goker-Alpan, MD

O+O Alpan LLC
Fairfax, VA United States
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Ron Scott

University of Washington
Seattle, WA United States
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William Rhead

Medical College of Wisconsin
Milwaukee, WI United States
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Kathleen Nicholls, MD

Royal Melbourne Hospital
Parkville, Australia
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Francois Eyskens, MD

UZ Antwerpen
Edegem, Belgium
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Michael L West, Md

Capital District Health Authority
Halifax, NS Canada
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Ales Linhart, MD

Vseobecna fakultni nemocnice v Praze
Prague, Czechia
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Christoph Wanner, MD

Universitaetsklinikum Wuerzburg
Würzburg, Germany
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Maria J Molnar, MD

Semmelweis Egyetem
Budapest, Hungary
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Eugenio E Minetti

Azienda Ospedaliero-Universitaria Careggi (SOD Nefrologia)
Firenze, Italy
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Raffaele Manna

Policlinico Universitario Agostino Gemelli, L.go A. Gemelli
Roma, Italy
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Mirjam Langeveld, MD, PhD

Academisch Medisch Centrum
Amsterdam, Netherlands
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Camilla Tøndel, MD

Haukeland University Hospital Klinisk Forskningspost
Bergen, Norway
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Derlis Emilio Gonzales Rodriguez, MD

Hematology and Clinical Research Private Institute
Asuncion, Paraguay
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Bojan Vujkovac

General Hospital Slovenj Gradec
Slovenj Gradec, Slovenia
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Pilar Giraldo, MD

Hospital de Dia Quiron Zaragoza
Zaragoza, Spain
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Fatih Ezgu, MD

Department and Laboratory of Pediatric Metabolic Disorders
Ankara, Turkey
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Sema Kalkan Ucar, MD

Ege Universty Medical Faculty
Izmir, Turkey
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Patrick Deegan, MD

Addenbrooke's Hospital
Cambridge, United Kingdom
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Robin Lachmann, MD

University College London Hospitals
London, United Kingdom
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Derralynn Hughes, MD

The Royal Free Hospital
London, United Kingdom
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Ana Jovanovic, MD

Salford Royal NHS Foundation Trust
Salford, United Kingdom
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