Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301
Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in de Novo Renal Transplant Patients|
- Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment.
- Incidence of biopsy proven acute rejection in the first six months of treatment in de novo renal transplant recipients.
- Efficacy of enteric-coated mycophenolate sodium
- Safety of enteric-coated mycophenolate sodium based on AE reporting.
- Pharmacokinetics (PK) of enteric-coated mycophenolate sodium (selected centers only).
|Study Start Date:||December 1999|
|Study Completion Date:||April 2003|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|