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Renal function at 12 months assessed by calculated creatinine clearance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine | Drug | Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped " |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids. | 6 months |
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Inclusion Criteria:
Other inclusion applies.
Exclusion Criteria:
Other exclusion applies.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Italy, decresg@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rome | Lazio | 00144 | Italy | |||
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| 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 |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D013256 | Steroids |
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Steroids | Drug | Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped " |
|
| Rapamune (Sirolimus) | Drug | Arm 1= Rapamune+ low dose Cyclosporine+steroids "Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped " |
|
| Rome |
| Lazio |
| 00168 |
| Italy |
| Palermo | Sicily | 90127 | Italy |
| Bari | 70100 | Italy |
| Bologna | 40138 | Italy |
| Cagliari | 09125 | Italy |
| Florence | 50139 | Italy |
| L’Aquila | 67100 | Italy |
| Milan | 20162 | Italy |
| Pisa | 56100 | Italy |
| Sassari | 07100 | Italy |
| Siena | 53100 | Italy |
| Udine | 37100 | Italy |
| Varese | 21100 | Italy |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007154 | Immune System Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000072473 | Fused-Ring Compounds |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |