Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
A 12-month Open-label, Randomized, Multicenter, Sequential Cohort, Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of Oral AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Corticosteroids in de Novo Adult Renal Transplant Recipients
1 other identifier
interventional
124
7 countries
41
Brief Summary
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 26, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedDecember 22, 2020
September 1, 2016
1.3 years
June 26, 2007
December 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies
Interventions
Eligibility Criteria
You may qualify if:
- Male and female patients of any race 18 years or older
- Adult recipients of kidney transplant from a deceased or living donor
- Recipients of a functioning kidney within 24 hours post transplant
You may not qualify if:
- Need for medication prohibited by the protocol
- Patients or donors infected with Hepatitis B,C or HIV
- Patients with a history of cancer within last 5 years
- Patients with history of significant cardiac disorder
- Patients of high-risk immunological status
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
USC Medical Center
Los Angeles, California, 90033, United States
University of California San Diego
San Diego, California, 92103-8401, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
UCSF
San Francisco, California, 94143, United States
University of Colorado Health Science Center
Denver, Colorado, 80262, 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
Henry Ford Hospital Transplant Institute
Detroit, Michigan, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Comprehensive Transplant Clinic
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati, Dept of Internal Medicine
Cincinnati, Ohio, United States
University of Toledo Health Science Campus
Toledo, Ohio, United States
University of Pennsylvania Health System-Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
Baylor U Medical Center
Dallas, Texas, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555 - 0561, United States
University of Utah
Salt Lake City, Utah, United States
U of Wisconsin Hospital Clinics
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
CHU Erasme
Brussels, Belgium
UZ Gasthuisberg
Leuven, Belgium
Saint Joseph's Hospital
Hamilton, Ontario, Canada
Queen Elizabeth II
Halifax, Canada
Hopital Maisonneuve-Rosemont
Montreal Quebec, Canada
Klinikum der Humboldt Universitat Charite
Berlin, Germany
Universitaetsklinik Charité
Berlin, Germany
Staedt. Kliniken Koeln-Merheim
Cologne, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Univ.-Klinikum Heidelberg
Heidelberg, Germany
Klinikum der Universitaet Regensburg
Regensburg, Germany
Hospital Juan Canalejo
A Coruña, Spain
Fundacion Puigvert
Barcelona, Spain
Enheten f Transpl och Leverkir, SU/Sahlgrenska
Gothenburg, Sweden
Transplantationskirurgiska mottagningen, Akademiska Sjukhuse
Uppsala, Sweden
Addenbrookes Hospital
Cambridge, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Related Publications (1)
Friman S, Arns W, Nashan B, Vincenti F, Banas B, Budde K, Cibrik D, Chan L, Klempnauer J, Mulgaonkar S, Nicholson M, Wahlberg J, Wissing KM, Abrams K, Witte S, Woodle ES. Sotrastaurin, a novel small molecule inhibiting protein-kinase C: randomized phase II study in renal transplant recipients. Am J Transplant. 2011 Jul;11(7):1444-55. doi: 10.1111/j.1600-6143.2011.03538.x. Epub 2011 May 12.
PMID: 21564523DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2007
First Posted
June 27, 2007
Study Start
January 1, 2007
Primary Completion
May 1, 2008
Last Updated
December 22, 2020
Record last verified: 2016-09