Bosutinib For Autosomal Dominant Polycystic Kidney Disease

Pfizer

Status and phase: Completed; Phase 2

Conditions: Polycystic Kidney, Autosomal Dominant

Treatments: Drug: Bosutinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01233869

3160A7-2211 (Other Identifier)

2010-023017-65 (EudraCT Number)

B1871019

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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172 participants in 3 patient groups, including a placebo group

Cohort A

Experimental group

Treatment:

Drug: Bosutinib

Drug: Bosutinib

Cohort B

Experimental group

Treatment:

Drug: Bosutinib

Drug: Bosutinib

Cohort C

Placebo Comparator group

Treatment:

Drug: Placebo