Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
NCT ID: NCT00114777
Last Updated: 2017-07-07
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
595 participants
INTERVENTIONAL
2005-02-28
2014-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
NCT00256750
A Belatacept Compassionate Use Study for Patients With a Kidney Transplant
NCT00719225
A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids
NCT00402168
Belatacept Pharmacokinetic Trial in Renal Transplantation
NCT00578448
Belatacept in Liver Transplant Recipients
NCT00555321
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cyclosporin A
Cyclosporin A
tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months
Belatacept Less Intensive Regimen (LI)
Belatacept Less Intensive Regimen (LI)
solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
Belatacept More Intensive Regimen (MI)
Belatacept More Intensive Regimen (MI)
solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cyclosporin A
tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months
Belatacept Less Intensive Regimen (LI)
solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
Belatacept More Intensive Regimen (MI)
solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
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
* Specific donor criteria
Exclusion Criteria
* Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.)
* Subjects with a positive T-cell lymphocytotoxic crossmatch.
* Subjects who are positive for Hepatitis B or C, or HIV
* Active tuberculosis
* History of cancer in the last 5 years
* History of substance abuse
* Specific laboratory results are exclusionary
* Mammography suspicious for cancer
* Allergy to iodine
* For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
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.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Of Alabama At Birmingham
Birmingham, Alabama, United States
Ucla Kidney & Kidney-Pancreas Transplant Research Office
Los Angeles, California, United States
National Institute Of Transplantation
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
University Of California San Francisco Medical Center
San Francisco, California, United States
University Of Colorado Health Sciences Center
Aurora, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Lifelink Healthcare Institute
Tampa, Florida, United States
Piedmont Transplant Institute
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern University-Feinberg School Of Medicine
Chicago, Illinois, United States
University Of Chicago Hospitals
Chicago, Illinois, United States
Acadiana Renal Physicians
New Iberia, Louisiana, United States
Tulane Abdominal Transplant Institute
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Western New England Renal & Transplant Associates, Pc
Springfield, Massachusetts, United States
Henry Ford Hospital, Transplant Institute
Detroit, Michigan, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Mount Sinai School Of Medicine
New York, New York, United States
Columbia University College Of Physicians & Surgeons
New York, New York, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Drexel University College Of Medicine, Department Of Surgery
Philadelphia, Pennsylvania, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
University Of Wisconsin
Madison, Wisconsin, United States
Froedtert Memorial Hospital
Milwaukee, Wisconsin, United States
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Cordoba, Crd, Córdoba Province, Argentina
Local Institution
Rosario, Santa Fe Province, Argentina
Local Institution
Santa Fe, , Argentina
Local Institution
Woodville, South Australia, Australia
Local Institution
Innsbuck, , Austria
Local Institution
Vienna, , Austria
Local Institution
Leuven, , Belgium
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Porto Alegre/rs, Rio Grande do Sul, Brazil
Local Institution
Campinas/sp, São Paulo, Brazil
Local Institution
Rio de Janeiro, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
São Paulo, , Brazil
Local Institution
Edmonton, Alberta, Canada
Local Institution
Halifax, Nova Scotia, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Saskatoon, Saskatchewan, Canada
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Prague, , Czechia
Local Institution
Bordeaux, , France
Local Institution
Brest, , France
Local Institution
Créteil, , France
Local Institution
Le Kremlin-Bicêtre, , France
Local Institution
Nantes, , France
Local Institution
Paris, , France
Local Institution
Toulouse, , France
Local Institution
Tours, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Local Institution
Berlin, , Germany
Local Institution
Berlin, , Germany
Local Institution
Erlangen, , Germany
Local Institution
Essen, , Germany
Local Institution
Hanover, , Germany
Local Institution
Budapest, , Hungary
Local Institution
Szeged, , Hungary
Local Institution
Milan, , Italy
Local Institution
Padua, , Italy
Local Institution
Roma, , Italy
Local Institution
Oslo, , Norway
Local Institution
Poznan, , Poland
Local Institution
Warsaw, , Poland
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
Barcelona, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Málaga, , Spain
Local Institution
Gothenburg, , Sweden
Local Institution
Manchester, , 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.
Dobbels F, Wong S, Min Y, Sam J, Kalsekar A. Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials. Transplantation. 2014 Nov 15;98(9):960-8. doi: 10.1097/TP.0000000000000159.
Pestana JO, Grinyo JM, Vanrenterghem Y, Becker T, Campistol JM, Florman S, Garcia VD, Kamar N, Lang P, Manfro RC, Massari P, Rial MD, Schnitzler MA, Vitko S, Duan T, Block A, Harler MB, Durrbach A. Three-year outcomes from BENEFIT-EXT: a phase III study of belatacept versus cyclosporine in recipients of extended criteria donor kidneys. Am J Transplant. 2012 Mar;12(3):630-9. doi: 10.1111/j.1600-6143.2011.03914.x. Epub 2012 Feb 2.
Related Links
Access external resources that provide additional context or updates about the study.
BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IM103-027
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.