Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Kidney Transplantation

Treatments: Drug: AEB071

Study type: Interventional

Funder types: Industry

Identifiers

NCT00492869

CAEB071A2207

Details and patient eligibility

About

Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• 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

Exclusion:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)