Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107
Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate sodium in regard to adverse events, serious adverse events and patient and graft survival. After successful completion of the study CERL080A0107 study, patients could continue to receive 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 Renal Transplant Patients.|
- To assess gastro-intestinal tolerability
- Efficacy/safety of enteric-coated mycophenolate sodium based on AE reporting.
|Study Start Date:||April 2000|
|Primary Completion Date:||April 2004 (Final data collection date for primary outcome measure)|
|Experimental: Mycophenolate sodium (enteric coated)||Drug: Mycophenolate sodium (enteric coated)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149916