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This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolic Acid / tacrolimus | Active Comparator |
| |
| AEB071 / tacrolimus arm 1 | Experimental |
| |
| AEB071 / tacrolimus arm 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AEB071 | Drug |
| ||
| Mycophenolic Acid |
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy failure, defined as a composite efficacy endpoint of treated biopsy-proven acute rejection (BPAR), graft loss, death or loss to follow-up | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function post-transplant Modification of diet in renal disease (MDRD) formula for Glomerular Filtration Rate) | at 6 months | |
| Primary efficacy failure, defined as a composite efficacy endpoint of treated BPAR, graft loss, death or loss to follow-up |
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Inclusion criteria
Exclusion criteria
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 |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143-0780 | United States | ||
| University Hospitals of Cleveland |
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| Label | URL |
|---|---|
| Results for CAEB071A2203 from the Novartis Clinical Trials website | View source |
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| Drug |
|
| at 3 and 12 months |
| Various efficacy endpoints, using treated BPAR, treated acute rejection (AR), death, graft loss, loss to follow-up and combinations thereof. | at Month 3, 6 and 12 |
| Changes in renal function (GFR) after replacing tacrolimus by myfortic in the AEB071 treatment arms | from Month 3 to Month 6 |
| Safety and tolerability | at 3, 6 and 12 months |
| Cleveland |
| Ohio |
| 44106-5048 |
| United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792-7375 | United States |
| QE II Health Sciences Center | Halifax | B3H 1V7 | Canada |
| Hopital Kremlin Bicetre | Le Kremlin-Bicêtre | 94270 | France |
| Hopital Hotel Dieu | Nantes | 44035 | France |
| Hopital Necker | Paris | 75015 | France |
| CHU de Rangueil | Toulouse | 31403 | France |
| Universitaetsklinik Charite | Berlin | 10117 | Germany |
| Klinikum der Humboldt Universitat Charite | Berlin | 13353 | Germany |
| Staedt. Krankenhaus Koeln-Merheim | Cologne | 51109 | Germany |
| Universitaetsklinikum Essen | Essen | 45122 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Univ. - Klinikum Heidelberg | Heidelberg | 69120 | Germany |
| Az. Osp. Di Bologna Polici. S. Orsola - Malpighi | Bologna | 40138 | Italy |
| Azienda Opedaliera Careggi - Universita degli Studi | Florence | 50134 | Italy |
| Azienda Ospedaliera di Padova - Universita degli Studi | Padova | 35128 | Italy |
| Ciutat Santitaria I Univessitaria de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Complejo Hospitalario Carlos Haya | Málaga | 28041 | Spain |
| Hospital Doctor Peset | Valencia | 46017 | Spain |
| Universitatsspital Basel | Basel | 4031 | Switzerland |
| Inselspital Bern | Bern | 3010 | Switzerland |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| Western Infirmary | Glasgow | G11 6NT | United Kingdom |
| Saint George's University of London | London | United Kingdom |
| Manchester Royal Infirmary | Manchester | United Kingdom |
| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C543528 | sotrastaurin |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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