At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 431 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Placebo-controlled, Double-blind Study on the Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease (ESRD) in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
In Brief
A Phase 4 clinical trial evaluating Placebo and Everolimus for Autosomal Dominant Polycystic Kidney Disease. Completed, enrolled 431 participants across 24 sites in 3 countries.
Detailed Summary
This study will assess whether everolimus (RAD001) is effective in preventing cyst and kidney expansion as well as worsening of renal function in patients with ADPKD and whether the application of 5 mg/day everolimus as monotherapy is safe and well tolerated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, France, Germany
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedDec 2006
Primary CompletionOct 2013
TodayJul 2026
First PostedDec 21, 2006
Enrollment StartDec 1, 2006
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 19.5 years ago
Interventions
Placebodrug
placebo comparator
Everolimusdrug
experimental