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 California San Diego
🇺🇸San Diego, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
UCSF
🇺🇸San Francisco, California, United States
University of Colorado Health Science Center
🇺🇸Denver, Colorado, 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
Scroll for more (31 remaining)USC Medical Center🇺🇸Los Angeles, California, United States