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Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant

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

Condition(s) targeted: Renal Transplantation

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

Summary

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.

Clinical Details

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

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

Primary outcome:

subject and graft survival

measured GFR and measured GFR change from baseline

Secondary outcome:

biopsy proven chronic allograft nephropathy

post-transplant diabetes mellitus, hypertension and dyslipidemia

Eligibility

Minimum age: 18 Years. Maximum age: N/A. 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

- For Long-term extension study-Subjects who have completed three years of study

treatment (through Week 156)

Locations and Contacts

Local Institution, Santa Fe S3000EPV, Argentina

Local Institution, Innsbuck 6020, Austria

Local Institution, Vienna 1090, Austria

Local Institution, Leuven 3000, Belgium

Local Institution, Rio De Janeiro 21041, Brazil

Local Institution, Sao Paulo 05403, Brazil

Local Institution, Sao Paulo 4038-002, Brazil

Local Institution, Prague 4 140 21, Czech Republic

Local Institution, Bordeaux 33076, France

Local Institution, Brest, Cedex 29 29609, France

Local Institution, Creteil 94000, France

Local Institution, Le Kremlin Bicetre Cedex 94275, France

Local Institution, Nante Cedex 01 44093, France

Local Institution, Paris 75015, France

Local Institution, Toulouse Cedex 31054, France

Local Institution, Tours Cedex 09 37044, France

Local Institution, Vandoeuvre Les Nancy Cedex 54511, France

Local Institution, Berlin 10117, Germany

Local Institution, Berlin 13353, Germany

Local Institution, Erlangen 91054, Germany

Local Institution, Essen 45147, Germany

Local Institution, Hannover 30625, Germany

Local Institution, Budapest 1082, Hungary

Local Institution, Szeged H-6720, Hungary

Local Institution, Milano 20162, Italy

Local Institution, Padova 35128, Italy

Local Institution, Roma 00168, Italy

Local Institution, Oslo N-0027, Norway

Local Institution, Poznan 60-479, Poland

Local Institution, Warszawa 02-006, Poland

Local Institution, Barcelona 08036, Spain

Local Institution, Barcelona 08907, Spain

Local Institution, Madrid 28040, Spain

Local Institution, Madrid 28041, Spain

Local Institution, Malaga 29010, Spain

Local Institution, Gothenburg 413 45, Sweden

Local Institution, Manchester M13 9WL, United Kingdom

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

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

Ucla Kidney & Kidney-Pancreas Transplant Research Office, Los Angeles, California 90024, United States

Sharp Memorial Hospital, San Diego, California 92133, United States

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

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

Yale University School Of Medicine, New Haven, Connecticut 06540, United States

Local Institution, Cordoba, Crd, Cordoba X5016KEH, Argentina

Lifelink Healthcare Institute, Tampa, Florida 33606, United States

Local Institution, Pretoria, Gauteng 0181, South Africa

Emory University Hospital, Atlanta, Georgia 30322, United States

Piedmont Transplant Institute, Atlanta, Georgia 30309, United States

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

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

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

Tulane Abdominal Transplant Institute, New Orleans, Louisiana 70112, United States

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

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

Local Institution, Santiago, Metropolitana, Chile

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

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

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

Local Institution, Halifax, Nova Scotia B3H 1V7, Canada

Drexel University College Of Medicine, Department Of Surgery, Philadelphia, Pennsylvania 19102, United States

University Of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Local Institution, Montreal, Quebec H3A 1A1, Canada

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/sp, Sao Paulo 13083, Brazil

Local Institution, Saskatoon, Saskatchewan S7M 0Z9, Canada

Local Institution, Woodville, South Australia 5011, Australia

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

University Of Wisconsin, Madison, Wisconsin 53792, United States

Froedtert Memorial 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: February 2005
Last updated: February 6, 2015

Page last updated: August 23, 2015

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