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The objectives of the study are:To compare the renal function of a quadruple immunosuppressive regimen (including basiliximab in combination with an optimized cyclosporine dose during the first weeks post-transplantation, mycophenolate mofetil and corticosteroids) versus a standard triple therapy regimen (including cyclosporine standard dose, mycophenolate mofetil and corticosteroids)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basiliximab | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of rejection episodes before 6 and 12 months post-transplantation | ||
| Frequency of death, graft loss or retransplantation before 6 and 12 months post-transplantation | ||
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Inclusion Criteria
Exclusion Criteria
Other protocol-defined exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
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| Adverse events |
| Duration of initial hospitalization and number or hospital re-admissions. |
| ID | Term |
|---|---|
| D000077552 | Basiliximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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