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The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric-Coated Mycophenolate Sodium | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biopsy proven acute rejection | ||
| Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms) | ||
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Inclusion Criteria:
First or second (single or double) deceased or living donor kidney transplant received at least six months previously;
Exclusion Criteria:
• Subjects expected to discontinue cyclosporin therapy;
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
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| Quality of life related to GI symptoms (GIQLI scale) |
| Full blood count |
| Gastrointestinal Adverse Events (check-list) |