Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
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A 12-month Open-label, Randomized, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male and female patients of any race 18 years or older
Adult recipients of kidney transplant from a deceased or living donor
Recipients of a functioning kidney within 24 hours post transplant
Need for medication prohibited by the protocol
Patients or donors infected with Hepatitis B,C or HIV
Patients with a history of cancer within last 5 years
Patients with history of significant cardiac disorder
Patients of high-risk immunological status
Other protocol-defined inclusion/exclusion criteria may apply.