Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
- Conditions
- Kidney Transplantation
- Registration Number
- NCT00492869
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies
Trial Locations
- Locations (41)
USC Medical Center
🇺🇸Los Angeles, California, United States
University of Cincinnati, Dept of Internal Medicine
🇺🇸Cincinnati, Ohio, United States
University of Colorado Health Science Center
🇺🇸Denver, Colorado, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Toledo Health Science Campus
🇺🇸Toledo, Ohio, United States
Klinikum der Humboldt Universitat Charite
🇩🇪Berlin, Germany
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Enheten f Transpl och Leverkir, SU/Sahlgrenska
🇸🇪Goteborg, Sweden
Universitaetsklinik Charité
🇩🇪Berlin, Germany
California Pacific Medical Center
🇺🇸San Francisco, California, United States
UCSF
🇺🇸San Francisco, California, United States
Lifelink, Inc.
🇺🇸Tampa, Florida, United States
U of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Hospital Transplant Institute
🇺🇸Detroit, Michigan, United States
Baylor U Medical Center
🇺🇸Dallas, Texas, United States
Comprehensive Transplant Clinic
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Texas Medical Branch at Galveston
🇺🇸Galveston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
U of Wisconsin Hospital Clinics
🇺🇸Madison, Wisconsin, United States
Saint Joseph's Hospital
🇨🇦Hamilton, Ontario, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montreal Quebec, Canada
Queen Elizabeth II
🇨🇦Halifax, Canada
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Univ.-Klinikum Heidelberg
🇩🇪Heidelberg, Germany
Staedt. Kliniken Koeln-Merheim
🇩🇪Koeln, Germany
Klinikum der Universitaet Regensburg
🇩🇪Regensburg, Germany
Hospital Juan Canalejo
🇪🇸La Coruna, Spain
Fundacion Puigvert
🇪🇸Barcelona, Spain
Churchill Hospital
🇬🇧Oxford, United Kingdom
Transplantationskirurgiska mottagningen, Akademiska Sjukhuse
🇸🇪Uppsala, Sweden
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Leicester General Hospital
🇬🇧Leicester, United Kingdom
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
University of California San Diego
🇺🇸San Diego, California, United States
CHU Erasme
🇧🇪Bruxelles, Belgium
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Pennsylvania Health System-Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States