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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Basiliximab; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

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.