Study of Enteric-coated Mycophenolate Sodium Maintenance Therapy in Patients With Renal Transplant Receiving Cyclosporine Microemulsion and Steroids,
The aim of this study is to evaluate if the addition of EC-MPS to CsA-ME allows the safe withdrawal of the concomitant corticosteroid therapy in long-term maintenance renal allograft recipients.
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.
Maintenance Renal Transplantation
Drug: Enteric-Coated Mycophenolate Sodium
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Enteric-Coated Mycophenolate Sodium (EC-MPS) Administration in Maintenance Renal Transplant Patients Receiving Cyclosporine Microemulsion (CsA-ME) and Steroids, for the Withdrawal of Concomitant Steroid Therapy: a Prospective, Open-label, Exploratory Study|
- Incidence of biopsy prove acute rejection requiring treatment within six months of the start of the study.
- Assessment of the changes in body-weight, blood pressure, serum lipid levels, renal function, glaciated hemoglobin, dermatological condition and quality of life six months after the start of the study
- Safety and tolerability
- Pharmacokinetics of MPA and MPAG in the patient subgroup that was receiving MMF (screening period) before the start of the study and two weeks after the start of the administration of EC-MPS.
|Study Start Date:||May 2002|
|Study Completion Date:||January 2005|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239057