Bosutinib For Autosomal Dominant Polycystic Kidney Disease

Summary

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.

Timeline

Start

2010-12

Primary completion

2014-07

Completion

2014-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Bosutinib 200 mg/Day vs Placebo; p = 0.0050; Median Difference (Final Values) 3.06 (95% CI 0.93 to 5.23); Mixed Models Analysis NCT01233869 ↗

paper The annual rate of kidney enlargement was reduced by 66% for bosutinib 200 mg/d versus placebo (1.63% versus 4.74%, respectively; P=0.01) PMID 28838955 ↗

Publications

• St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
• Tesar V, Ciechanowski K, Pei Y, Barash I, Shannon M, Li R, Williams JH, Levisetti M, Arkin S, Serra A. Bosutinib versus Placebo for Autosomal Dominant Polycystic Kidney Disease. J Am Soc Nephrol. 2017 Nov;28(11):3404-3413. doi: 10.1681/ASN.2016111232. Epub 2017 Aug 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bosutinib	Small molecule	200 mg	Oral
Subject	Bosutinib	Small molecule	400 mg	Oral

Indications