Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant 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.
The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.
|Kidney de Novo Transplant||Drug: Enteric-coated Mycophenolate sodium (EC-MPS)||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Randomized, Open Label, Multicenter Trial of EC-MPS With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen for the Prevention of Acute Rejection Episodes in de Novo Renal Transplant Recipients.|
- biopsy proven acute rejection incidence at 1 year post-transplantation
- Incidence of biopsy proven acute rejection episodes at 6 months
- Incidence of treated rejection episodes at 6 months and 1 year
- Incidence of steroid-resistant episodes at 6 months and 1 year
- Patient and graft survival at 1 year
- Cardiovascular profile (as measured by Cholesterol, HbA1, Glucose, incidence of HTA)
- Percentage of patients free from steroids at 6 months and 1 year
- Treatment safety
|Study Start Date:||December 2002|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238992