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Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplantation; Chronic Kidney Failure

Intervention: CsA (Drug); Belatacept LI (Drug); Belatacept MI (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb


The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.

Clinical Details

Official title: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome:

The composite of subject and graft survival

The composite of measured GFR <60ml/min/1.73 m2

A decrease in measured GFR >= 10mL/min/1.73m2

The incidence of acute rejection

Secondary outcome:

Measured GFR

Biopsy-proven chronic allograft nephropathy


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- The subject is a recipient of a living donor or deceased donor kidney transplant.

- Male or Female, 18 or older

Exclusion Criteria:

- First time recipient, PRA >- 50% or for retransplantation PRA >- 30%.

- 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)

Locations and Contacts

Local Institution, Buenos Aires C1155APP, Argentina

Local Institution, Santa Fe S3000EPV, Argentina

Local Institution, Innsbuck 6020, Austria

Local Institution, Vienna 1090, Austria

Local Institution, Gent 9000, Belgium

Local Institution, Leuven 3000, Belgium

Local Institution, Sao Paulo 05403, Brazil

Local Institution, Praha 4 140 21, Czech Republic

Local Institution, Bordeaux 33076, France

Local Institution, Brest Cedex 29609, France

Local Institution, Creteil 94000, France

Local Institution, Grenoble Cedex 9 38043, France

Local Institution, Nante Cedex 01 44093, France

Local Institution, Paris 75015, France

Local Institution, Toulouse 31054, France

Local Institution, Berlin 13353, Germany

Local Institution, Erlangen 91054, Germany

Local Institution, Essen 45122, Germany

Local Institution, Hannover 30625, Germany

Local Institution, Szeged H-6720, Hungary

Local Institution, Chandigarh 160012, India

Local Institution, Chennai 600 006, India

Local Institution, Lucknow 226000, India

Local Institution, New Delhi 110076, India

Local Institution, Petah Tikva 49100, Israel

Local Institution, Milano 20162, Italy

Local Institution, Padova 35128, Italy

Local Institution, Roma 00168, Italy

Local Institution, Aguascalientes 20000, Mexico

Local Institution, Distrito Federal 14080, Mexico

Local Institution, San Luis Potosi 78240, Mexico

Local Institution, Poznan 60-479, Poland

Local Institution, Szczecin 70-111, Poland

Local Institution, Barcelona 08907, Spain

Local Institution, Madrid 28040, Spain

Local Institution, Malaga 29010, Spain

Local Institution, Goteborg SE-413 45, Sweden

Local Institution, Bern 3010, Switzerland

Local Institution, Zurich 8091, Switzerland

Local Institution, Antalya 07059, Turkey

Local Institution, Gujarat, Ahmedabad 380016, India

University Of Alabama At Birmingham, Birmingham, Alabama 35294, United States

Local Institution, Edmonton, Alberta T6G 2S2, Canada

Local Institution, Capital Federal, Buenos Aires C1425APQ, Argentina

Local Institution, La Plata, Buenos Aires 1900, Argentina

Loma Linda University Medical Center-Transplantation Institu, Loma Linda, California 92354, United States

Cedars Sinai Medical Center, Los Angeles, California 90048, United States

California Institute Of Renal Research, San Diego, California 92123, United States

University Of California San Francisco Medical Center, San Francisco, California 94143, United States

Local Institution, Observatory, Cape Town 7925, South Africa

University Of Colorado Health Sciences Center, Aurora, Colorado 80045, United States

Yale University School Of Medicine-Yale New Haven Hospital, New Haven, Connecticut 06520, United States

Local Institution, Cordoba, Crd, Cordoba X5016KEH, Argentina

Local Institution, Mexico, Distrito Federal 14080, Mexico

Local Institution, Pretoria, Gauteng 0002, South Africa

Emory University Hospital, Atlanta, Georgia 30322, United States

Piedmont Hospital, Atlanta, Georgia 30309, United States

Medical College Of Georgia, Augusta, Georgia 30912, United States

Local Institution, Nadiad, Gujarat 387001, India

Local Institution, Ahmedabad, Gujrat 380052, India

University Of Chicago Hospitals, Chicago, Illinois 60637, United States

University Of Iowa Hospitals And Clinics, Iowa City, Indiana 52242, United States

University Of Kentucky, Lexington, Kentucky 40536, United States

Local Institution, Cochin, Kerala 682304, India

Local Institution, Durban, Kwa Zulu Natal 4001, South Africa

Local Institution, Mumbai, Maharashtra 400 026, India

Local Institution, Mumbai, Maharashtra 400016, India

Maine Tranplant Program, Portland, Maine 04102, United States

Western New England Renal & Transplant Associates, Pc, Springfield, Massachusetts 01107, United States

Henry Ford Hospital, Transplant Institute, Detriot, Michigan 48202, United States

University Of Minnesota, Minneapolis, Minnesota 55455, United States

Washington University School Of Medicine, Saint Louis, Missouri 63110, United States

Local Institution, Cuernavaca, Morelos 62448, Mexico

Local Institution, Camperdown, New South Wales 2050, Australia

Local Institution, Westmead, New South Wales 2145, Australia

Columbia University College Of Physicians & Surgeons, New York, New York 10032, United States

Recanati/Miller Transplantation Institute, New York, New York 10029, United States

University Of Rochester Medical Center, Rochester, New York 14642, United States

University Of North Carolina At Chapel Hill, Chapel Hill, North Carolina 27599, United States

Carolinas Medical Center, Charlotte, North Carolina 28203, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Local Institution, Halifax, Nova Scotia B3H 2Y9, Canada

Local Institution, Monterrey, Nuevo Leon 64460, Mexico

Div Of Multi-Organ Trans, Hepato-Biliary-Pancreatic Surgery, Philadelphia, Pennsylvania 19102, United States

Local Institution, Montreal, Quebec H1T 2M4, Canada

Local Institution, Montreal, Quebec H2L 2W5, Canada

Local Institution, Montreal, Quebec H3A 1A1, Canada

Local Institution, Rio De Janeiro / Rj, Rio De Janeiro 21041, Brazil

Local Institution, Porto Alegre/rs, Rio Grande Do Sul 90035, Brazil

Local Institution, Porto Alegre, Rio Grande Do Sul 90035, Brazil

Local Institution, Rosario, Santa Fe 2000, Argentina

Local Institution, Campinas, Sao Paulo 13033, Brazil

Local Institution, Sao Paulo/sp, Sao Paulo 04038, Brazil

Local Institution, Saskatoon, Saskatchewan S7M 0Z9, Canada

Local Institution, Adelaide, South Australia 5000, Australia

Musc, Charleston, South Carolina 29425, United States

Vanderbilt University Medical Center, Nashville, Tennessee 27232, United States

Baylor University Medical Center, Dallas, Texas 75246, United States

Fletcher Allen Health Care, Burlington, Vermont 05401, United States

Local Institution, Parkville, Victoria 3052, Australia

Inova Transplant Center, Fairfax, Virginia 22031, United States

Swedish Medical Center, Seattle, Washington 98104, United States

Sacred Heart Medical Ctr Providence Medical Research Ctr, Spokane, Washington 99204, United States

University Of Wisconsin, Madison, Wisconsin 53792, United States

Froedtert Memorial Lutheran Hospital, Milwaukee, Wisconsin 53226, United States

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: March 2005
Last updated: May 18, 2015

Page last updated: August 23, 2015

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