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This study looks at the drug Sirolimus compared with conventional therapy to evaluate its effectiveness and safety on the kidneys in adults with autosomal dominant polycystic kidney disease. Adults over 18 who had been diagnosed with this disease and whose kidney function was above a certain level could take part. The study was carried out in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Age \>18 years * Clinical and ultrasound diagnosis of ADPKD * GFR \>40 ml/min/1.73 m2 (estimated by the 4 variable MDRD equation) * Urinary protein excretion rate ≤ 0.5 g/ 24 hrs * Written informed consent Exclusion Criteria: * Diabetes * Urinary protein excretion rate \>0.5 g/ 24 hrs or abnormal urinalysis suggestive of concomitant, clinically significant glomerular disease * Urinary tract lithiasis, infection or obstruction * Cancer * Psychiatric disorders and any condition that might prevent full comprehension of the purposes and risks of the study * Pregnancy, lactation or child bearing potential and ineffective contraception (estrogen therapy in post menopausal women should not be stopped)