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This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric-Coated Mycophenolate Sodium (EC-MPS) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety based on renal function within 6 months after medication switch. | ||
| Pharmacokinetics (PK) in a randomized subpopulation. | ||
| Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch. |
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Inclusion/ Exclusion criteria
- Only patients who were participating in study CERL080A2405-DE02 and have completed the first 6 months of the core study can be included in this additional extension study.
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
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| Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch. |
| Graft survival and patient survival 6 months post medication switch. |