Bosutinib versus Placebo for Autosomal Dominant Polycystic Kidney Disease
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F17%3A10365058" target="_blank" >RIV/00216208:11110/17:10365058 - isvavai.cz</a>
Alternative codes found
RIV/00064165:_____/17:10365058
Result on the web
<a href="http://dx.doi.org/10.1681/ASN.2016111232" target="_blank" >http://dx.doi.org/10.1681/ASN.2016111232</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1681/ASN.2016111232" target="_blank" >10.1681/ASN.2016111232</a>
Alternative languages
Result language
angličtina
Original language name
Bosutinib versus Placebo for Autosomal Dominant Polycystic Kidney Disease
Original language description
Overactivation of Src has been linked to the pathogenesis of autosomal dominant polycystic kidney disease (ADPKD). This phase 2, multisite study assessed the efficacy and safety of bosutinib, an oral dual Src/Bcr-Abl tyrosine kinase inhibitor, in patients with ADPKD. Patients with ADPKD, eGFR >= 60 ml/min per 1.73 m(2), and total kidney volume >= 750 ml were randomized 1: 1: 1 to bosutinib 200 mg/d, bosutinib 400 mg/d, or placebo for <= 24 months. The primary endpoint was annualized rate of kidney enlargement in patients treated for >= 2 weeks who had at least one postbaseline magnetic resonance imaging scan that was preceded by a 30-day washout (modified intent-to-treat population). Of 172 enrolled patients, 169 received at least one study dose. Per protocol amendment, doses for 24 patients who initially received bosutinib at 400 mg/d were later reduced to 200 mg/d. 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) and by 82% for pooled bosutinib versus placebo (0.84% versus 4.74%, respectively; P < 0.001). Over the treatment period, patients receiving placebo or bosutinib had similar annualized eGFR decline. Gastrointestinal and liver-related adverse events were the most frequent toxicities. In conclusion, compared with placebo, bosutinib at 200 mg/d reduced kidney growth in patients with ADPKD. The overall gastrointestinal and liver toxicity profile was consistent with the profile in prior studies of bosutinib; no new toxicities were identified.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30217 - Urology and nephrology
Result continuities
Project
—
Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2017
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Journal of the American Society of Nephrology
ISSN
1046-6673
e-ISSN
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Volume of the periodical
28
Issue of the periodical within the volume
11
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
3404-3413
UT code for WoS article
000414419000030
EID of the result in the Scopus database
2-s2.0-85032629031