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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015456-14 | EudraCT Number |
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This study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo renal transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | sotrastaurin (100mg bid) + tacrolimus + standard of care medications |
|
| Arm 2 | Experimental | sotrastaurin (200mg bid) + tacrolimus + standard of care medications |
|
| Arm 3 | Experimental | sotrastaurin (300mg bid) + tacrolimus + standard of care medications |
|
| Arm 4 | Active Comparator | mycophenolic acid (720mg bid) + tacrolimus + standard of care medications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sotrastaurin (Dose 1) + tacrolimus + standard of care medications | Drug | sotrastaurin (100mg bid) + tacrolimus + standard of care medications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost to follow up). | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockroft-Gault formula; serum creatinine) | Months 6, 12, 24, and 36 | |
| Demonstrate that at least one of the sotrastaurin + tacrolimus treatment arms is non-inferior to the active control regimen with respect to composite efficacy failure (treated BPAR of grade IA or higher, graft loss, death or lost 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 |
| Novartis Pharmceuticals | Novartis Pharmceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35233 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23668931 | Result | Russ GR, Tedesco-Silva H, Kuypers DR, Cohney S, Langer RM, Witzke O, Eris J, Sommerer C, von Zur-Muhlen B, Woodle ES, Gill J, Ng J, Klupp J, Chodoff L, Budde K. Efficacy of sotrastaurin plus tacrolimus after de novo kidney transplantation: randomized, phase II trial results. Am J Transplant. 2013 Jul;13(7):1746-56. doi: 10.1111/ajt.12251. Epub 2013 May 13. |
| Label | URL |
|---|---|
| Novartis Results on CAEB071A2214 from the Novartis Clinical Trials Website | View source |
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| sotrastaurin (Dose 2) + tacrolimus + standard of care medications | Drug | sotrastaurin (200mg bid) + tacrolimus + standard of care medications |
|
| sotrastaurin (Dose 3) + tacrolimus + standard of care medications | Drug | sotrastaurin (300mg bid) + tacrolimus + standard of care medications |
|
| mycophenolic acid + tacrolimus + standard of care medications | Drug | mycophenolic acid (720mg bid) + tacrolimus + standard of care medications |
|
| Months 12, 24, and 36 |
| Evaluate individual components of the composite efficacy endpoint (treated BPAR, severity of acute rejections by Banff 2007 diagnostic category). | Months 6, 12, 24, and 36 |
| Evaluate safety and tolerability (adverse events, serious adverse events, laboratory abnormalities, vital signs, electrocardiograms, physical examination). | Months 6, 12, 24, and 36 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Novartis Investigative Site | Ann Arbor | Michigan | 48109 | United States |
| Novartis Investigative Site | Detroit | Michigan | 48202-2689 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45219 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45267-0585 | United States |
| Novartis Investigative Site | Madison | Wisconsin | 53792 | United States |
| Novartis Investigative Site | Corrientes | W3400 | Argentina |
| Novartis Investigative Site | Córdoba | X5016KEH | Argentina |
| Novartis Investigative Site | Córdoba | X5022CPU | Argentina |
| Novartis Investigative Site | Camperdown | New South Wales | 2050 | Australia |
| Novartis Investigative Site | Woolloongabba | Queensland | 4102 | Australia |
| Novartis Investigative Site | Adelaide | South Australia | 5000 | Australia |
| Novartis Investigative Site | Melbourne | Victoria | 3050 | Australia |
| Novartis Investigative Site | Brussels | 1070 | Belgium |
| Novartis Investigative Site | Brussels | 1200 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 04023-900 | Brazil |
| Novartis Investigative Site | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Novartis Investigative Site | Cali | Colombia |
| Novartis Investigative Site | Aarhus | 8000 C | Denmark |
| Novartis Investigative Site | Berlin | 10098 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Cologne | 51109 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Regensburg | 93053 | Germany |
| Novartis Investigative Site | Budapest | 1082 | Hungary |
| Novartis Investigative Site | Szeged | 6720 | Hungary |
| Novartis Investigative Site | Rotterdam | 3015 CE | Netherlands |
| Novartis Investigative Site | Coimbra | 3000-075 | Portugal |
| Novartis Investigative Site | Lisbon | 1069-166 | Portugal |
| Novartis Investigative Site | Porto | 4099-001 | Portugal |
| Novartis Investigative Site | Seoul | Korea | 120-752 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 138-736 | South Korea |
| Novartis Investigative Site | Gothenburg | SE-413 45 | Sweden |
| Novartis Investigative Site | Stockholm | 141 86 | Sweden |
| Novartis Investigative Site | Uppsala | 751 85 | Sweden |
| Novartis Investigative Site | Glasgow | G11 6NT | United Kingdom |
| Novartis Investigative Site | Leicester | LE5 4PW | United Kingdom |
| Novartis Investigative Site | Manchester | M13 9WL | United Kingdom |
| ID | Term |
|---|---|
| C543528 | sotrastaurin |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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