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The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of EC-MPS
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric-Coated Mycophenolate Sodium (EC-MPS) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess glomerular filtration rate at month 3 post transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function of patients requiring post transplantation dialysis, experiencing slow graft function (defined as S. Creat level>264 μmol/l at D5) or with immediate graft function. | ||
| Incidence of patients requiring post transplantation dialysis, experience slow graft function (defined as S. Creat level>264 μmol/l at D5 or with immediate graft function. |
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Inclusion / Exclusion Criteria
- All patients who completed study CERL080A2405-FR01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.
Other protocol-defined inclusion / exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
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| Incidence of biopsy proven acute rejection, any treated acute rejection, and any treated acute rejection requiring antibody therapy, recurrent acute rejection and the severity of acute rejection episodes within 6 and 12 months |
| Incidence of graft and patient survival within 6 and 12 months |
| Safety and tolerability based on adverse event (AE) reporting. |