A 24 month extension to a 12-month open label, randomized, multicenter study evaluating efficacy, safety and tolerability of oral AEB071 plus tacrolimus (converted to myfortic® after 3 months), vs. myfortic® plus tacrolimus in de novo renal transplant recipients
- Conditions
- The study is a continuation of a CNI-sparing study in which 2/3rds of patients were converted to a non CNI regimen after 3 months (core study). The others remained on a CNI Control arm. The extension will allow continued access to AEB071 after the end of the core trial, and also to the control arm patients who were on study treatment at the end of the core study. The data may provide early notification of safety signals on AEB071 in patients during the 24 months follow-up period.
- Registration Number
- EUCTR2007-002986-11-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
•The patient has given written informed consent to participate in the extension study.
•The patient has been maintained on AEB071/myfortic® or tacrolimus/myfortic®, consistent with their original randomization, at their core study Month 12 visit.
•Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Inability or unwillingness to comply with the immunosuppressive regimen.
•Pregnancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method