Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation
December 15, 2020 updated by: Novartis Pharmaceuticals
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
Efficacy and safety of AEB071 in combination with mycophenolate acid sodium, basiliximab and steroids in preventing acute rejection after kidney transplantation.
Study Overview
Study Type
Interventional
Enrollment (Actual)
124
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bruxelles, Belgium
- CHU Erasme
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Leuven, Belgium
- UZ Gasthuisberg
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Halifax, Canada
- Queen Elizabeth II
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Montreal Quebec, Canada
- Hopital Maisonneuve-Rosemont
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Ontario
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Hamilton, Ontario, Canada
- Saint Joseph's Hospital
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Berlin, Germany
- Klinikum der Humboldt Universitat Charite
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Berlin, Germany
- Universitaetsklinik Charite
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Hannover, Germany
- Medizinische Hochschule Hannover
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Heidelberg, Germany
- Univ.-Klinikum Heidelberg
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Koeln, Germany
- Staedt. Kliniken Koeln-Merheim
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Regensburg, Germany
- Klinikum der Universitaet Regensburg
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Barcelona, Spain
- Fundación Puigvert
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La Coruna, Spain
- Hospital Juan Canalejo
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Goteborg, Sweden
- Enheten f Transpl och Leverkir, SU/Sahlgrenska
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Uppsala, Sweden
- Transplantationskirurgiska mottagningen, Akademiska Sjukhuse
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Cambridge, United Kingdom
- Addenbrookes Hospital
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Leicester, United Kingdom
- Leicester General Hospital
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Oxford, United Kingdom
- Churchill Hospital
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California
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Los Angeles, California, United States, 90033
- USC Medical Center
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San Diego, California, United States, 92103-8401
- University of California San Diego
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San Francisco, California, United States, 94115
- California Pacific Medical Center
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San Francisco, California, United States, 94143
- UCSF
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Colorado
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Denver, Colorado, United States, 80262
- University of Colorado Health Science Center
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Florida
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Tampa, Florida, United States
- Lifelink, Inc.
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Maryland
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Baltimore, Maryland, United States
- U of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States
- Brigham and Women's Hospital
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Michigan
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Ann Arbor, Michigan, United States
- University of Michigan Health System
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Detroit, Michigan, United States
- Henry Ford Hospital Transplant Institute
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New Jersey
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Livingston, New Jersey, United States, 07039
- Saint Barnabas Medical Center
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New York
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New York, New York, United States, 10029
- Mount Sinai Medical Center
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New York, New York, United States
- Comprehensive Transplant Clinic
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North Carolina
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Durham, North Carolina, United States
- Duke University Medical Center
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Ohio
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Cincinnati, Ohio, United States
- University of Cincinnati, Dept of Internal Medicine
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Toledo, Ohio, United States
- University of Toledo Health Science Campus
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Health System-Presbyterian Medical Center
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Texas
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Dallas, Texas, United States
- Baylor U Medical Center
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Galveston, Texas, United States, 77555 - 0561
- University of Texas Medical Branch at Galveston
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Utah
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Salt Lake City, Utah, United States
- University of Utah
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Wisconsin
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Madison, Wisconsin, United States
- U of Wisconsin Hospital Clinics
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Milwaukee, Wisconsin, United States
- Medical College of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion:
- 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
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
Other protocol-defined inclusion/exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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Renal function assessed by calculated and measured glomerular filtration rate (GFR). Incidence of Chronic Allograft Nephropathy using biopsies
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
June 26, 2007
First Submitted That Met QC Criteria
June 26, 2007
First Posted (Estimate)
June 27, 2007
Study Record Updates
Last Update Posted (Actual)
December 22, 2020
Last Update Submitted That Met QC Criteria
December 15, 2020
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CAEB071A2207
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.