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| ID | Type | Description | Link |
|---|---|---|---|
| B1741188 | Other Identifier | Pfizer |
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The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sirolimus | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR) | ||
| Non-inferiority of the composite of graft loss and death at 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks | ||
| quality of life at 24, 52 and 104 weeks |
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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 Germany, MedInfoDEU@wyeth.com | Principal Investigator |
| Trial Manager | For Norway, Sweden, MedInfoNord@wyeth.com | Principal Investigator |
| Trial Manager | For Australia, Taiwan, medinfo@wyeth.com | Principal Investigator |
| Trial Manager | For Austria, WPVIMED@wyeth.com | Principal Investigator |
| Trial Manager | For Italy, Greece, decresg@wyeth.com | Principal Investigator |
| Trial manager | For Hungary, WPBUMED@wyeth.com | Principal Investigator |
| Trial Manager | For Turkey, Erisc@wyeth.com | Principal Investigator |
| Trial Manager | For South Africa, ZAFinfo@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | 92123 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23689085 | Derived | Flechner SM, Gurkan A, Hartmann A, Legendre CM, Russ GR, Campistol JM, Schena FP, Hahn CM, Li H, Korth-Bradley JM, Tai SS, Schulman SL. A randomized, open-label study of sirolimus versus cyclosporine in primary de novo renal allograft recipients. Transplantation. 2013 May 27;95(10):1233-41. doi: 10.1097/TP.0b013e318291a269. |
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| Trial Manager |
| For Argentina, Chile, scheima@wyeth.com, rendop@wyeth.com |
| Principal Investigator |
| Trial Manager | For UK, ukmedonfo@wyeth.com | Principal Investigator |
| Trial Manager | For Switzerland, med@wyeth.com | Principal Investigator |
| San Francisco |
| California |
| 94143 |
| United States |
| Denver | Colorado | 80262 | United States |
| New Haven | Connecticut | 06520 | United States |
| Gainesville | Florida | 32610 | United States |
| Tampa | Florida | 33606 | United States |
| Atlanta | Georgia | 30309 | United States |
| Chicago | Illinois | 60612-3824 | United States |
| Portland | Maine | 04102 | United States |
| Springfield | Massachusetts | 01199 | United States |
| Detroit | Michigan | 48202 | United States |
| New York | New York | 10029 | United States |
| Charlotte | North Carolina | 28203 | United States |
| Durham | North Carolina | 27710 | United States |
| Cleveland | Ohio | 44106 | United States |
| Cleveland | Ohio | 44195 | United States |
| Toledo | Ohio | 43614 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Philadelphia | Pennsylvania | 19129 | United States |
| Providence | Rhode Island | United States |
| Charleston | South Carolina | 29425 | United States |
| Dallas | Texas | 75246 | United States |
| Houston | Texas | 77225 | United States |
| Buenos Aires | Capital Ferderal | 1093 | Argentina |
| Buenos Aires | Capital Ferderal | 1155 | Argentina |
| Buenos Aires | Capital Ferderal | 1425 | Argentina |
| Buenos Aires | Capital Ferderal | C1118AT | Argentina |
| Buenos Aires | Capital Ferderal | C1425APQ | Argentina |
| Buenos Aires | CP1900 | Argentina |
| Ciudad de Bs As | Argentina |
| Córdoba | 5000 | Argentina |
| Córdoba | Argentina |
| Camperdown | NSW 2050 | Australia |
| Parkville | 3050 | Australia |
| Randwick | 2031 | Australia |
| Westmead | 2145 | Australia |
| Woodville South | SA 5011 | Australia |
| Woolloongabba | QLD 4102 | Australia |
| Vienna | A-1090 | Austria |
| London | Ontario | N6A 5A5 | Canada |
| Cote Du Palais | Quebec | G1R 2J6 | Canada |
| Montreal | Quebec | H2L 4M1 | Canada |
| Puente Alto | Chile |
| Santiago | Chile |
| Talca | Chile |
| Viña del Mar | Chile |
| Nicosia | 1102 | Cyprus |
| Montpellier | 34059 | France |
| Paris | 75747 | France |
| Münster | 48149 | Germany |
| Athens | 11527 | Greece |
| Thessaloniki | 54642 | Greece |
| Budapest | 1083 | Hungary |
| Debrecen | 4012 | Hungary |
| Pécs | 7621 | Hungary |
| Szeged | 6720 | Hungary |
| Bari | 70124 | Italy |
| Cagliari | 09134 | Italy |
| Torino | 10126 | Italy |
| Oslo | 0027 | Norway |
| Carnaxide-lisboa | 2795-563 | Portugal |
| Coimbra | 3049 | Portugal |
| Lisbon | 81050 | Portugal |
| Singapore | 169608 | Singapore |
| Cape Town | 7925 | South Africa |
| Cape Town | 8001 | South Africa |
| Johannesburg | 2193 | South Africa |
| Barcelona | 08036 | Spain |
| La Coruã'a | 15006 | Spain |
| La Laguna / Santa Cruz de Tenerife | 38320 | Spain |
| Madrid | 28040 | Spain |
| Madrid | 28041 | Spain |
| Santander | 39008 | Spain |
| Valencia | 46009 | Spain |
| Uppsala | SE-751 85 | Sweden |
| Taipei | 100 | Taiwan |
| Antalya | 07070 | Turkey (Türkiye) |
| Istanbul | 34390 | Turkey (Türkiye) |
| Izmir | 35100 | Turkey (Türkiye) |
| Glasgow | G11 6NT | United Kingdom |
| Leicester | LE5 4PW | United Kingdom |
| Manchester | M13 9WL | United Kingdom |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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