3 results
CAEB071A2206 will assess safety, efficacy and target trough levels for optimal dosing of AEB071 combined with Certican in a CNI-free regimen in de novo renal transplant recipients. This study will combine the investigational drug AEB071 with an…
There will be three formal interim analyses during the study. Interim Analysis 1 will occur at the end of Phase II when approximately 162 PFS events (defined as disease progression or death due to any cause, whichever occurs first) have been…
The purpose of this extension is to provide continued treatment and to assess the long term safety, efficacy and tolerability of oral AEB071 plus Certican® vs. Neoral® plus Certican® in de novo renal transplant recipients. The study is a…