This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
215
University of California, San Francisco
Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up
Time frame: at 6 months
Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate)
Time frame: at 6 months
Primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up
Time frame: at 3 and 12 months
Various efficacy endpoints, using treated BPAR, treated acute rejection (AR), death, graft loss, loss to follow-up and combinations thereof.
Time frame: at Month 3, 6 and 12
Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms
Time frame: from Month 3 to Month 6
Safety and tolerability
Time frame: at 3, 6 and 12 months
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San Francisco, California, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
QE II Health Sciences Center
Halifax, Canada
Hopital Kremlin Bicetre
Le Kremlin-Bicêtre, France
Hopital Hotel Dieu
Nantes, France
Hopital Necker
Paris, France
CHU de Rangueil
Toulouse, France
Universitaetsklinik Charite
Berlin, Germany
Klinikum der Humboldt Universitat Charite
Berlin, Germany
...and 18 more locations