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To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric-coated Mycophenolate sodium (EC-MPS) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatic function tests (ALT/AST) after 12 months treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Acumulative incidence of biopsy proven acute rejection after 3 and 12 months. | ||
| Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment. | ||
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
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| Glomerular filtration rate and by proteinuria after 12 months treatment. |
| Graft survival after 12 months. |
| Incidence of AEs and SAEs after 3 and 12 months. |
| Blood pressure, lipids and glucose profiles after 3 and 12 months. |
| Percentage of patients free of steroids at 12 months between the two investigational groups. |
| Viral load (HCV RNA) between both groups at 12 months. |
| Bone density at 12 months in both groups. |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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