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To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12 post-transplantation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney function at 52 weeks after transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney function at 26, 78 and 104 weeks after transplantation |
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Inclusion Criteria:
Other inclusions apply.
Exclusion Criteria:
Other exclusions apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth Reseach | Study Director |
| Trial Manager | For Belgium, trials-BEL@wyeth.com | Principal Investigator |
| Trial Manager | For France, infomedfrance@wyeth.com | Principal Investigator |
| Trial Manager | For Germany, MedinfoDEU@wyeth.com | Principal Investigator |
| Trial Manager | For Italy, decresg@wyeth.com | Principal Investigator |
| Trial Manager | For Poland, WPWZMED@wyeth.com | Principal Investigator |
| Trial Manager | For Spain, infomed@wyeth.com | Principal Investigator |
| Trial Manager | For Switzerland, med@wyeth.com | Principal Investigator |
| Trial Manager | For United Kingdom, ukmedinfo@wyeth.com | Principal Investigator |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |