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Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEB071 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy will be defined using a composite efficacy failure end point (treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up) between treatment and control arms |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies |
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Inclusion:
Exclusion:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Medical Center | Los Angeles | California | 90033 | United States | ||
| University of California San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21564523 | Derived | Friman S, Arns W, Nashan B, Vincenti F, Banas B, Budde K, Cibrik D, Chan L, Klempnauer J, Mulgaonkar S, Nicholson M, Wahlberg J, Wissing KM, Abrams K, Witte S, Woodle ES. Sotrastaurin, a novel small molecule inhibiting protein-kinase C: randomized phase II study in renal transplant recipients. Am J Transplant. 2011 Jul;11(7):1444-55. doi: 10.1111/j.1600-6143.2011.03538.x. Epub 2011 May 12. |
| Label | URL |
|---|---|
| Results for CAEB071A2207 from the Novartis Clinical Trials website | View source |
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| San Diego |
| California |
| 92103-8401 |
| United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| UCSF | San Francisco | California | 94143 | United States |
| University of Colorado Health Science Center | Denver | Colorado | 80262 | United States |
| Lifelink, Inc. | Tampa | Florida | United States |
| U of Maryland Medical Center | Baltimore | Maryland | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | United States |
| University of Michigan Health System | Ann Arbor | Michigan | United States |
| Henry Ford Hospital Transplant Institute | Detroit | Michigan | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Comprehensive Transplant Clinic | New York | New York | United States |
| Duke University Medical Center | Durham | North Carolina | United States |
| University of Cincinnati, Dept of Internal Medicine | Cincinnati | Ohio | United States |
| University of Toledo Health Science Campus | Toledo | Ohio | United States |
| University of Pennsylvania Health System-Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Baylor U Medical Center | Dallas | Texas | United States |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 - 0561 | United States |
| University of Utah | Salt Lake City | Utah | United States |
| U of Wisconsin Hospital Clinics | Madison | Wisconsin | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | United States |
| CHU Erasme | Brussels | Belgium |
| UZ Gasthuisberg | Leuven | Belgium |
| Saint Joseph's Hospital | Hamilton | Ontario | Canada |
| Queen Elizabeth II | Halifax | Canada |
| Hopital Maisonneuve-Rosemont | Montreal Quebec | Canada |
| Klinikum der Humboldt Universitat Charite | Berlin | Germany |
| Universitaetsklinik Charité | Berlin | Germany |
| Staedt. Kliniken Koeln-Merheim | Cologne | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Univ.-Klinikum Heidelberg | Heidelberg | Germany |
| Klinikum der Universitaet Regensburg | Regensburg | Germany |
| Hospital Juan Canalejo | A Coruña | Spain |
| Fundacion Puigvert | Barcelona | Spain |
| Enheten f Transpl och Leverkir, SU/Sahlgrenska | Gothenburg | Sweden |
| Transplantationskirurgiska mottagningen, Akademiska Sjukhuse | Uppsala | Sweden |
| Addenbrookes Hospital | Cambridge | United Kingdom |
| Leicester General Hospital | Leicester | United Kingdom |
| Churchill Hospital | Oxford | United Kingdom |
| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C543528 | sotrastaurin |
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