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

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Kidney Transplantation

Treatments: Drug: AEB071; Drug: Mycophenolic Acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00403416

CAEB071A2203

Details and patient eligibility

About

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.

Enrollment: 215 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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215 participants in 3 patient groups

Mycophenolic Acid / tacrolimus

Active Comparator group

Treatment:

Drug: Mycophenolic Acid

AEB071 / tacrolimus arm 1

Experimental group

Treatment:

Drug: AEB071

AEB071 / tacrolimus arm 2

Experimental group

Treatment:

Drug: AEB071