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Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate sodium (enteric coated) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of EC-MPS compared to MMF in Chinese patients as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant recipients. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of biopsy proven acute rejection within six months of treatment in de novo renal transplant recipients | ||
| Other variables of efficacy: chronic rejection, graft loss, death. | ||
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital, Friendship Hospital, Beijing, No 1 Hospital Peking University, Beijing China; Shanghai No 1 Hospital, Shanghai China; Changzheng Hospital, Shanghai, China; Shanghai Ruij | Beijing | China |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Safety of EC-MPS as measured by incidence of adverse events and serious adverse events. |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |