Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
NCT ID: NCT00492869
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
124 participants
INTERVENTIONAL
2007-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AEB071
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adult recipients of kidney transplant from a deceased or living donor
* Recipients of a functioning kidney within 24 hours post transplant
Exclusion:
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Henry Ford Hospital Transplant Institute
Detroit, Michigan, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Mount Sinai Medical Center
New York, New York, 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, United States
Baylor U Medical Center
Dallas, Texas, 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
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Results for CAEB071A2207 from the Novartis Clinical Trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAEB071A2207
Identifier Type: -
Identifier Source: org_study_id