Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients|
- Safety parameters and graft function in maintenance renal transplant recipients.
- Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.
|Study Start Date:||August 2002|
|Study Completion Date:||January 2005|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
|Experimental: EC-MPS arm||Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241059
|Study Director:||Novartis Pharmaceuticals||Novartis|