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New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine micro-emulsion | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who no longer require a hypoglycemic agent, or who move from insulin to an oral agent, or who no longer meet the American Diabetes Association criteria, or a relative improvement in mean glycosylated hemoglobin at 12 and 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by death, graft loss, biopsy supported clinically manifested acute rejection, change in kidney function, change in liver function, serious adverse events and adverse events at 12 and 26 weeks |
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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 |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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