This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
137
200mg oral b.i.d.
720mg b.i.d. 2yrs
Novartis Investigative Site
San Francisco, California, United States
Long term safety assessed by and renal safety defined by measuring renal function using Modification of Diet in Renal Disease (MDRD) formula for Glomerular Filtration Rate (GFR) beyond 12 months.
Time frame: three Yrs
Efficacy assessed by: the incidence over 36 months of the composite endpoint of biopsy proven rejection ≥ 1A, graft loss, death, or loss to follow-up in the two study arms.
Time frame: Three yrs
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Novartis Investigative Site
Madison, Wisconsin, United States
Novartis Investigative Site
Halifax, Canada
Novartis Investigative Site
Le Kremlin-Bicêtre, France
Novartis Investigative Site
Nantes, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Toulouse, France
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Cologne, Germany
...and 17 more locations