Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.
Phase 3
Completed
- Conditions
- Kidney de Novo Transplant
- Registration Number
- NCT00238992
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 144
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method biopsy proven acute rejection incidence at 1 year post-transplantation
- Secondary Outcome Measures
Name Time Method 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