Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant

Condition(s) targeted: Renal Transplantation

Intervention: Belatacept (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

Official title: Belatacept Evaluation of Nephroprotection and Efficacy as First-Line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)

Study design: Interventional, Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety Study

Primary outcome:

subject and graft survival

measured GFR and measured GFR change from baseline

Secondary outcome: biopsy proven chronic allograft nephropathy by 12 months; post-transplant diabetes mellitus, hypertension and dyslipidemia at 12, 24 and 36 months;

Minimum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subject is a first-time recipient of a kidney transplant from a deceased donor.

- Specific donor criteria

Exclusion Criteria:

- Donor age <10 years

- 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 TB

- History of cancer in the last 5 years

- History of substance abuse

- Specific laboratory results are exclusionary

- Mammography suspicious for cancer

- Allergy to iodine

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

Local Institution, Edmonton, Alberta T6G 2S2, Canada

Local Institution, Capital Federal, Buenos Aires 1425, Argentina

Local Institution, Capital Federal, Buenos Aires C1155APP, Argentina

Local Institution, La Planta, Buenos Aires 1900, Argentina

University Of California San Francisco Medical Center, San Francisco, California 94122, United States

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

National Institute Of Transplantation, Los Angeles, California 90057, United States

Ucla Kidney & Pancreas Transplant Research Office, Los Angeles, California 90095, United States

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

Local Institution, Col. Centro, Chihuahua 31000, Mexico

University Of Colorado Health Sciences Center, Denver, Colorado 80262, United States

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

Local Institution, Cordoba, Crd, Cordoba X5016KEH, Argentina

University Of Miami School Of Medicine, Miami, Florida 33136, United States

The University Of Forida College Of Medicine, Gainsville, Florida 32610, United States

Lifelink, Tampa, Florida 33606, United States

Local Institution, Pretoria, Gauteng 0002, South Africa

Emory University Hospital, Atlanta, Georgia 30322, United States

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

Piedmont Hospital, Atlanta, Georgia 30309, United States

Local Institution, Cardiff, Glamorgan CF14 4XW, United Kingdom

Local Institution, Graz 8036, Austria

Local Institution, Vienna 1090, Austria

Local Institution, Innsbruck 6020, Austria

Local Institution, Leuven 3000, Belgium

Local Institution, Ghent 9000, Belgium

Local Institution, Santa Fe S3000EPV, Argentina

Local Institution, Warszawa 02-006, Poland

Local Institution, Rio De Janeiro 21041, Brazil

Local Institution, Sao Paulo 04038, Brazil

Local Institution, Sao Paulo 05403, Brazil

Local Institution, Prague 4 140 21, Czech Republic

Local Institution, Nantes Cedex 1 44093, France

Local Institution, Brest Cedex 29009, France

Local Institution, Tours Cedex 37044, France

Local Institution, Le Kremlin Bicetre 94270, France

Local Institution, Vandoeuvre Les Nancy 54500, France

Local Institution, Creteil Cedex 94010, France

Local Institution, Toulouse Cedex 4 31403, France

Local Institution, Grenoble Cedex 9 F38043, France

Local Institution, Bordeaux Cedex 33076, France

Local Institution, Paris 75015, France

Local Institution, Erlangen 91054, Germany

Local Institution, Berlin 10117, Germany

Local Institution, Essen 45147, Germany

Local Institution, Hannover 30625, Germany

Local Institution, Berlin 13353, Germany

Local Institution, Budapest 1082, Hungary

Local Institution, Szeged H-6720, Hungary

Local Institution, Pecs H-7624, Hungary

Local Institution, Bergamo 24128, Italy

Local Institution, Padova 35128, Italy

Local Institution, Roma 00168, Italy

Local Institution, Milano 20162, Italy

Local Institution, Bologna 40138, Italy

Local Institution, Oslo 0027, Norway

Local Institution, Poznan 60-479, Poland

Local Institution, Szczecin 70-111, Poland

Local Institution, Genova 16132, Italy

Local Institution, Barcelona 08907, Spain

Local Institution, Madrid 28041, Spain

Local Institution, Madrid 28040, Spain

Local Institution, Barcelona 08036, Spain

Local Institution, Malaga 29010, Spain

Local Institution, Gothenburg 41345, Sweden

Local Institution, Geneva 1211, Switzerland

Local Institution, Zürich 8048, Switzerland

Local Institution, Bern 3010, Switzerland

Local Institution, Antalya 07059, Turkey

Local Institution, Izmir 35120, Turkey

Local Institution, Ankara 06490, Turkey

Northwestern University-Feinberg School Of Medicine, Chicago, Illinois 60611, United States

Rush University, Chicago, Illinois 60612, United States

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

Local Institution, Chicago, Illinois 60612, United States

Local Institution, Springfield, Illinois 62702, United States

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

Local Institution, Guadalajara, Jalisco 44349, Mexico

University Of Kentucky, Lexington, Kentucky 40536, United States

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

Local Institution, Manchester, Lancashire M13 9WL, United Kingdom

Tulane University Hospital And Clinic, New Orleans, Louisiana 70112, United States

Acadiana Renal Associates, New Iberia, Louisiana 70563, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Local Institution, Boston, Massachusetts 02114, United States

Wnerta, Springfield, Massachusetts 01107, United States

Local Institution, Santiago, Metropolitana 00, Chile

Henry Ford Hospital, Detriot, Michigan 48202, United States

University Of Minnesota, Minneapolis, Minnesota 55455, United States

Washington University School Of Medicine, St. Louis, Missouri 63110, United States

Saint Barnabas Medical Center, Livingston, New Jersey 07039, United States

Local Institution, Camperdown, New South Wales 2050, Australia

Mount Sinai School Of Medicine, New York, New York 10029, United States

Albany Medical Center Hospital, Albany, New York 12208, United States

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

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

Unc-Ch, Chapel Hill, North Carolina 27599, United States

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

Local Institution, Monterrey, Nuevo Leon 64320, Mexico

University Of Cincinnati, Cincinnati, Ohio 45267, United States

Cleveland Clinic, Cleveland, Ohio 44195, United States

Local Institution, Cincinnati, Ohio 45267, United States

Local Institution, Toronto, Ontario M5C2T2, Canada

University Of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Hahnemann University Hospital, Philadelphia, Pennsylvania 19102, United States

Local Institution, Montreal, Quebec H3A 1A1, Canada

Local Institution, Porto Alegre, Rio Grande Do Sul 90020, Brazil

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

Local Institution, Rosario, Santa Fe 2000, Argentina

Local Institution, Campinas, Sao Paulo 13083.888, Brazil

Local Institution, Saskatoon, Saskatchewan S7M 0Z9, Canada

Local Institution, Adelaide, South Australia 5011, Australia

Dallas Transplant Institute, Dallas, Texas 75204, United States

Dallas Transplant Institute, Dallas, Texas 75204, United States

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

University Of Virginia Health System, Charlottesville, Virginia 22908, United States

Inova Transplant Center, Fairfax, Virginia 22031, United States

Swedish Medical Center, Seattle, Washington 98104, United States

Providence Medical Research Center, Spokane, Washington 99204, United States

Local Institution, Birmingham, West Midlands B16 2EH, United Kingdom

Local Institution, Observatory, Western Cape 7925, South Africa

Medical College Of Wisconsin, Milwaukee, Wisconsin 53226, United States

University Of Wisconsin, Madison, Wisconsin 53792, United States

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: March 2005
Last updated: September 26, 2007