Bosutinib For Autosomal Dominant Polycystic Kidney Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Polycystic Kidney, Autosomal Dominant

In brief

This purpose of this study is to determine if bosutinib reduces the rate of kidney enlargement in subjects with autosomal dominant polycystic kidney disease (ADPKD) entering the study with a total kidney volume greater than or equal to 750 cc and eGFR greater than or equal to 60 mL/min/1.73m2.

Key facts

Study ID

NCT01233869

Run by

Pfizer

People needed

172

Starts

2010-12-01

Expected to finish

2014-08-01

Last updated by the study team

2016-03-11

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, 18 to 50 years old at the time of consent.
• Documented diagnosis of ADPKD (PKD-1 or PKD-2 genotypes allowed).
• Total kidney volume ≥ 750 cc, as measured by centrally evaluated MRI.

You may not qualify if…

• eGFR < 60 mL/min/1.73m2.
• Uncontrolled hypertension (defined as systolic blood pressure ≥140 or diastolic blood pressure ≥90 mm Hg).
• Any previous exposure to the bosutinib test article or receipt of other polycystic kidney disease (PKD) therapies.

Where it is running

• Southwest Clinical Research Institute, LLC — Tempe, Arizona, United States
• Southwest Kidney Institute, PLC — Tempe, Arizona, United States
• Capital Nephrology Clinical Research — Sacramento, California, United States
• Boise Kidney & Hypertension Institute, PLLC — Caldwell, Idaho, United States
• Boise Kidney & Hypertension Institute, PLLC — Meridian, Idaho, United States
• Renal Associates of Baton Rouge — Baton Rouge, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• New York University - HHC CTSI Clinical Research Center — New York, New York, United States
• Doylestown Hospital MRI — Doylestown, Pennsylvania, United States
• Doylestown Hospital — Doylestown, Pennsylvania, United States
• Nephrology/Hypertension Specialists — Doylestown, Pennsylvania, United States
• Renal Associates, PA — San Antonio, Texas, United States
• San Antonio Kidney Disease Center Physicians Group, P.L.L.C. — San Antonio, Texas, United States
• University of Virginia Health System - Nephrology — Charlottesville, Virginia, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• The Polyclinic — Seattle, Washington, United States
• Renal Remission and Hypertension Clinic — Silverdale, Washington, United States
• Monash Medical Centre — Clayton, Victoria, Australia
• Toronto General Hospital — Toronto, Ontario, Canada
• Hopital du Sacre-Coeur de Montreal — Montreal, Quebec, Canada
• Klinika gerontologicka a metabolicka — Hradec Králové, Czechia
• Krajska nemocnice Liberec — Liberec, Czechia
• Southwest Kidney Institute, PLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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