Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
NCT ID: NCT00300274
Last Updated: 2012-08-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
721 participants
INTERVENTIONAL
2006-01-31
2011-07-31
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
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
everolimus 1.5 mg
Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
everolimus
Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.
cyclosporine
Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.
corticosteroids
Corticosteroids standard dose.
everolimus 3.0 mg
Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
Randomization of new patients in this arm was prematurely stopped as of 27 March 2008 due to high mortality rate, as per Data Monitoring Committee.
everolimus
Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.
cyclosporine
Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.
corticosteroids
Corticosteroids standard dose.
mycophenolate mofetil
Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
mycophenolate mofetil
Mycophenolate mofetil supplied as 500 mg tablets.
cyclosporine
Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.
corticosteroids
Corticosteroids standard dose.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
everolimus
Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.
mycophenolate mofetil
Mycophenolate mofetil supplied as 500 mg tablets.
cyclosporine
Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.
corticosteroids
Corticosteroids standard dose.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The graft must be functional at time of randomization.
Exclusion Criteria
* Patients who are recipients of ABO incompatible transplants.
18 Years
70 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
Role: STUDY_DIRECTOR
Novartis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA Medical Center
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
Stanford U Sch, Falk Cardiovasular Research Ctr.
Stanford, California, United States
University of Florida Shands Hospital
Gainesville, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Loyola Univerisity Medical School
Maywood, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Recanati Miller Transplant Institute
New York, New York, United States
UNC Division of Cardiology
Chapel Hill, North Carolina, United States
Duke University Heart Failure Research
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Penn State College of Medicine
Hershey, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Cardiovascular Consultants
Austin, Texas, United States
University of Texas Medical Branch, Div of Cardio Thoracic
Galveston, Texas, United States
Methodist Hospital/DeBakey Heart Failure Research Center
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Wisconsin - Madison Medical School
Madison, Wisconsin, United States
St. Luke's Medical Center Cardiac Services
Milwakee, Wisconsin, United States
Sanatorio Parque
Rosario, Santa Fe Province, Argentina
Fundacion Favalaro
Buenos Aires, , Argentina
St Vincents Hospital
Darlinghurst, New South Wales, Australia
Prince Charles Hospital
Chermside, Queensland, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Universitaet Wien
Vienna, , Austria
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
University of Alberta Hospital
Edmonton, Alberta, Canada
St Paul's Hospital
Vancouver, British Columbia, Canada
New Halifax Infirmary
Halifax, Nova Scotia, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Institut Univ. de cardiologie et pneumologie de Quebec
Sainte-Foy, Quebec, Canada
Hopital Cardiologique de Lyon
Lyon, , France
Hopital Georges Pompidou
Paris, , France
Hopital Pitie Salpetriere
Paris, , France
CHU de Strasbourg Hopital Civil Medicale B
Strasbourg, , France
CHU Hopital de Brabois
Vandœuvre-lès-Nancy, , France
Herz- u. Diabeteszentrum NRW/Ruhr-Univ. Bochum
Bad Oeynhausen, , Germany
Deutsches Herzzentrum Berlin
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Kliniken der Med. Hochschule
Hanover, , Germany
Universitaetsklinikum Kiel
Kiel, , Germany
Universitaetsklinik Regensburg
Regensburg, , Germany
Az. Osp. di Bologna Policl. S. Orsola-Malpighi Univ. degli Studi
Bologna, , Italy
Azienda Ospedaliera G. Brotzu
Cagliari, , Italy
A.O.-Universita di Padova-Universita degli Studi
Padua, , Italy
Fodazione IRCCS Policlinico S. Matteo
Pavia, , Italy
Azienda Ospedaliera S. Camillo-Forlanini
Roma, , Italy
Az. Ospedaliero-Universitaria S. Giovanni Battista di Torino
Torino, , Italy
Auckland Hospital
Auckland, , New Zealand
Rikshospitalet, Hjertemedisinskavdeling
Oslo, , Norway
Cardiovascular Center of Puerto Rico and the Caribbean
San Juan, , Puerto Rico
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Puerta de Hierro Majadahonda
Madrid, , Spain
National Taiwan University Hospital
Taipei, , Taiwan
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Papworth Hospital
Cambridge, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRAD001A2310
Identifier Type: -
Identifier Source: org_study_id