Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
NCT ID: NCT00256750
Last Updated: 2016-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
738 participants
INTERVENTIONAL
2005-03-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cyclosporine (CsA)
Cyclosporine (CsA)
tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months (ST), 100-250 ng/mL, daily, 24 months (LT)
Belatacept LI (less intensive)
Belatacept LI (less intensive)
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 (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Belatacept MI (more intensive)
Belatacept MI (more intensive)
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 (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Interventions
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Cyclosporine (CsA)
tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months (ST), 100-250 ng/mL, daily, 24 months (LT)
Belatacept LI (less intensive)
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 (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Belatacept MI (more intensive)
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 (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Eligibility Criteria
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Inclusion Criteria
* Male or Female, 18 or older
Exclusion Criteria
* If retransplantation, previous graft loss cannot be due to acute rejection.
* Positive cross match.
* Subject receiving extended criteria donor (ECD) organ
* For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Alabama At Birmingham
Birmingham, Alabama, United States
Loma Linda University Medical Center-Transplantation Institu
Loma Linda, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
California Institute Of Renal Research
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-Yale New Haven Hospital
New Haven, Connecticut, United States
Piedmont Hospital
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Medical College Of Georgia
Augusta, Georgia, United States
University Of Chicago Hospitals
Chicago, Illinois, United States
University Of Iowa Hospitals And Clinics
Iowa City, Indiana, United States
University Of Kentucky
Lexington, Kentucky, United States
Maine Tranplant Program
Portland, Maine, United States
Western New England Renal & Transplant Associates, Pc
Springfield, Massachusetts, United States
Henry Ford Hospital, Transplant Institute
Detriot, Michigan, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Recanati/Miller Transplantation Institute
New York, New York, United States
Columbia University College Of Physicians & Surgeons
New York, New York, United States
University Of Rochester Medical Center
Rochester, 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
Duke University Medical Center
Durham, North Carolina, United States
Div Of Multi-Organ Trans, Hepato-Biliary-Pancreatic Surgery
Philadelphia, Pennsylvania, United States
Musc
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Inova Transplant Center
Fairfax, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Sacred Heart Medical Ctr Providence Medical Research Ctr
Spokane, Washington, United States
University Of Wisconsin
Madison, Wisconsin, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Cordoba, Crd, Córdoba Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Camperdown, New South Wales, Australia
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Westmead, New South Wales, Australia
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Adelaide, South Australia, Australia
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Parkville, Victoria, Australia
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Innsbuck, , Austria
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Vienna, , Austria
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Ghent, , Belgium
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Leuven, , Belgium
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Rio de Janeiro / Rj, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre/rs, Rio Grande do Sul, Brazil
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Campinas, São Paulo, Brazil
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Sao Paulo/sp, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Prague, , Czechia
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Bordeaux, , France
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Brest, , France
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Créteil, , France
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Grenoble, , France
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Nantes, , France
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Paris, , France
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Toulouse, , France
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Berlin, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Hanover, , Germany
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Szeged, , Hungary
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Gujarat, Ahmedabad, India
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Chandigarh, Chandigarh, India
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Ahmedabad, Gujarat, India
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Nadiād, Gujarat, India
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Kochi, Kerala, India
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Mumbai, Maharashtra, India
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Mumbai, Maharashtra, India
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Chennai, , India
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Lucknow, , India
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New Delhi, , India
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Petah Tikva, , Israel
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Milan, , Italy
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Padua, , Italy
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Roma, , Italy
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Aguascalientes, Aguascalientes, Mexico
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Distrito Federal, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Cuernavaca, Morelos, Mexico
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Monterrey, Nuevo León, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Poznan, , Poland
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Szczecin, , Poland
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Observatory, Cape Town, South Africa
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Pretoria, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Barcelona, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Gothenburg, , Sweden
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Bern, , Switzerland
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Zurich, , Switzerland
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Antalya, , Turkey (Türkiye)
Countries
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References
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Vincenti F, Rostaing L, Grinyo J, Rice K, Steinberg S, Gaite L, Moal MC, Mondragon-Ramirez GA, Kothari J, Polinsky MS, Meier-Kriesche HU, Munier S, Larsen CP. Belatacept and Long-Term Outcomes in Kidney Transplantation. N Engl J Med. 2016 Jan 28;374(4):333-43. doi: 10.1056/NEJMoa1506027.
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.
Vincenti F, Larsen CP, Alberu J, Bresnahan B, Garcia VD, Kothari J, Lang P, Urrea EM, Massari P, Mondragon-Ramirez G, Reyes-Acevedo R, Rice K, Rostaing L, Steinberg S, Xing J, Agarwal M, Harler MB, Charpentier B. Three-year outcomes from BENEFIT, a randomized, active-controlled, parallel-group study in adult kidney transplant recipients. Am J Transplant. 2012 Jan;12(1):210-7. doi: 10.1111/j.1600-6143.2011.03785.x. Epub 2011 Oct 12.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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IM103-008
Identifier Type: -
Identifier Source: org_study_id
NCT00432497
Identifier Type: -
Identifier Source: nct_alias
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