Overview
Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302
Status:
Completed
Completed
Trial end date:
2003-12-01
2003-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Aim of study is to collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of the study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF to enteric-coated mycophenolate sodium.Phase:
Phase 3Details
Lead Sponsor:
NovartisTreatments:
Mycophenolate mofetil
Mycophenolic Acid
Criteria
Inclusion Criteria:-First cadaveric, living unrelated or living related donor kidney transplant recipients who
completed study CERL080A302
Exclusion Criteria:
- Other protocol-defined inclusion/exclusion criteria may apply.