Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001776-36 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 liver transplantation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | MMF(1000mg bid) + tacrolimus + standard of care medications |
|
| Arm 2 | Experimental | sotrastaurin (200mg bid) + tacrolimus + standard of care medications |
|
| Arm 3 | Experimental | sotrastaurin (200mg bid) + tacrolimus + standard of care medications |
|
| Arm 4 | Experimental | sotrastaurin (300 mg bid) + tacrolimus + standard of care medications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMF(1000mg bid) + tacrolimus + standard of care medications | Drug | MMF(1000mg bid) + tacrolimus + standard of care medications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate renal allograft function post-transplantation (estimated GFR by MDRD equation; estimated creatinine clearance by Cockcroft-Gault formula; serum creatinine). | Months 3, 6, 12, and 24 | |
| Occurrence of primary efficacy failure defined as composite efficacy endpoint (treated BPAR of Banff grade ≥ 1, graft loss, or death) in the different treatment arms. |
Not provided
Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis Pharmceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Los Angeles | California | 90095 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25677074 | Result | Pascher A, De Simone P, Pratschke J, Salame E, Pirenne J, Isoneimi H, Bijarnia M, Krishnan I, Klupp J. Protein kinase C inhibitor sotrastaurin in de novo liver transplant recipients: a randomized phase II trial. Am J Transplant. 2015 May;15(5):1283-92. doi: 10.1111/ajt.13175. Epub 2015 Feb 12. |
| Label | URL |
|---|---|
| Results for CAEB071B2201 from the Novartis Clinical Trials Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sotrastaurin (200mg bid) + tacrolimus + standard of care medications | Drug | sotrastaurin (200mg bid) + tacrolimus + standard of care medications |
|
| sotrastaurin (200mg bid) + tacrolimus + standard of care medications | Drug | sotrastaurin (200mg bid) + tacrolimus + standard of care medications |
|
| sotrastaurin (300 mg bid) + tacrolimus + standard of care medications | Drug | sotrastaurin (300 mg bid) + tacrolimus + standard of care medications |
|
| Months 12, 24 |
| Occurrence of rejection requiring T-cell depleting antibody, occurrence of treated biopsy-proven acute rejections of Banff grade ≥ 1 that is steroid-resistant | Months 6, 12, 24 |
| Safety and tolerability ((serious) adverse events (specifically: gastrointestinal AEs and cardiac AEs, serious infections), laboratory abnormalities, vital signs, electrocardiograms, physical examination). | Months 3, 6, 12, 24 |
| San Francisco |
| California |
| 94143 |
| United States |
| Novartis Investigative Site | Detroit | Michigan | 48202-2689 | United States |
| Novartis Investigative Site | Minneapolis | Minnesota | 55455 | United States |
| Novartis Investigative Site | Rochester | Minnesota | 55905 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45219 | United States |
| Novartis Investigative Site | Dallas | Texas | 75246 | United States |
| Novartis Investigative Site | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | CABA | Buenos Aires | C1118AAT | Argentina |
| Novartis Investigative Site | CABA | Buenos Aires | C1181ACH | Argentina |
| Novartis Investigative Site | San Martín | Buenos Aires | C1107BEA | Argentina |
| Novartis Investigative Site | Innsbruck | A-6020 | Austria |
| Novartis Investigative Site | Vienna | A-1090 | Austria |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | London | Ontario | N6A 4G5 | Canada |
| Novartis Investigative Site | Prague | Czech Republic | 140 21 | Czechia |
| Novartis Investigative Site | Brno | 656 91 | Czechia |
| Novartis Investigative Site | HUS | 00029 | Finland |
| Novartis Investigative Site | Bordeaux | 33076 | France |
| Novartis Investigative Site | Chambray-lès-Tours | 37044 | France |
| Novartis Investigative Site | Créteil | 94000 | France |
| Novartis Investigative Site | Paris | 75012 | France |
| Novartis Investigative Site | Strasbourg | 67098 | France |
| Novartis Investigative Site | Villejuif | 94805 | France |
| Novartis Investigative Site | Berlin | 13353 | 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 | Milan | MI | 20162 | Italy |
| Novartis Investigative Site | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Pisa | PI | 56124 | Italy |
| Novartis Investigative Site | Seville | Andalusia | 41013 | Spain |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Novartis Investigative Site | A Coruña | Galicia | 15006 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46026 | Spain |
| Novartis Investigative Site | Zurich | 8091 | Switzerland |
| ID | Term |
|---|---|
| C494814 | BID protein, human |
| D016559 | Tacrolimus |
| C543528 | sotrastaurin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided