Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients

Study Overview
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Brief Summary
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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.

Official Title
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12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: AEB071
* Drug: Mycophenolic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Male and female patients of any race 18 years or older Adult recipients of a kidney transplant from a deceased or from a living donor Recipients of a functioning Kidney:. Graft must be functional no later than 36h after transplantation. Exclusion criteria Need for medication prohibited by the protocol Patients or donors infected with hepatitis B or C, or with HIV. Patients with a history of cancer Patients with severe systemic infections Patients with heart diseases (own or family history) which are associated with an increased risk for arrhythmias. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mycophenolic Acid / tacrolimus<br> | Drug: Mycophenolic Acid<br> <br> |
| Experimental: AEB071 / tacrolimus arm 1<br> | Drug: AEB071<br> <br> |
| Experimental: AEB071 / tacrolimus arm 2<br> | Drug: AEB071<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate) |  | at 6 months | 
| Primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up |  | 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. |  | at Month 3, 6 and 12 | 
| Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms |  | from Month 3 to Month 6 | 
| Safety and tolerability |  | at 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunosuppression, AEB071, Tacrolimus, Mycophenolic acid, Basiliximab, Rejection, Kidney function