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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric-coated Mycophenolate sodium (EC-MPS) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| biopsy proven acute rejection incidence at 1 year post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
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| 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 |