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

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.

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

Details

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

Criteria

Inclusion criteria:

• Participation in core study CAEB071A2203

• The patient has been maintained on AEB071/mycophenolic acid or tacrolimus/mycophenolic acid, consistent with their original randomization, at their core study Month 12 visit.

• Women capable of becoming pregnant are required to practice a medically approved method of birth control as long as they are on study medication and for a period of 3 months following discontinuation of study drug(s).

Exclusion criteria:

• Pregnancy. Other protocol-defined inclusion/exclusion criteria may apply