Status:
COMPLETED
Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Autosomal Dominant Polycystic Kidney Disease
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief 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 m...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Clinical diagnosis of autosomal dominant polycystic kidney disease ADPKD
- Chronic kidney disease (CKD) stage II / III
- Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility
- Exclusion Criteria
- ADPKD patients with normal renal function
- ADPKD patients with CKD stage IV
- Patients with a history of subarachnoid bleeding
- Patients with a history of severe infections
- Patients with life-threatening urinary tract or cyst infection in the past
- Patients who have received any investigational drug within four weeks prior to baseline
- Patients who have been treated with any non-protocol immunosuppressive drug or treatment within one month prior to baseline
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
431 Patients enrolled
Trial Details
Trial ID
NCT00414440
Start Date
December 1 2006
End Date
October 1 2013
Last Update
January 14 2015
Active Locations (24)
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1
Novartis Investigative Site
Innsbruck, Austria, INNSBRUCK
2
Novartis Investigative Site
Linz, Austria, A-4010
3
Novartis Investigative Site
Vienna, Austria, 1090
4
Novartis Investigative Site
Brest, France, 29200