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Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CYCLOSPORINE | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Calculated creatinine clearance at 12 months post transplantation for patients on therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Calculated creatinine clearance at 6 months Serum creatinine at 6 and 12 months post-transplantation. Graft survival at 6 and 12 months post-transplantation. Incidence of biopsy confirmed acute graft rejections at 6 and 12 months post transplantation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Brazil, xavierl@wyeth.com | Principal Investigator |
| Trial Manager | For Mexico, gomezlj@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Curitiba | Paraná | 80730-150 | Brazil | |||
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| Rio de Janeiro |
| Rio de Janeiro |
| 21041-030 |
| Brazil |
| Rio de Janeiro | Rio de Janeiro | 21941-590 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Ribeirao Preto | Rio Grande do Sul | 14048-900 | Brazil |
| São José do Rio Preto | São Paulo | 15015-200 | Brazil |
| São Paulo | São Paulo | 01323-001 | Brazil |
| São Paulo | São Paulo | 04038-002 | Brazil |
| São Paulo | São Paulo | 05403-000 | Brazil |
| Chihuahua City | Chihuahua | Mexico |
| Torreón | Coahuila | 27000 | Mexico |
| Mexico City DF | 14000 | Mexico |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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