Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.
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|ClinicalTrials.gov Identifier: NCT00238992|
Recruitment Status : Completed
First Posted : October 14, 2005
Last Update Posted : November 2, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney de Novo Transplant||Drug: Enteric-coated Mycophenolate sodium (EC-MPS)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||December 2002|
|Primary Completion Date :||July 2005|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238992