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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00256750
First received: November 15, 2005
Last updated: October 13, 2014
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Chronic Kidney Failure
Drug: CsA
Drug: Belatacept LI
Drug: Belatacept MI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The composite of subject and graft survival [ Time Frame: by 12 months ] [ Designated as safety issue: No ]
  • The composite of measured GFR <60ml/min/1.73 m2 [ Time Frame: at Month 12 ] [ Designated as safety issue: No ]
  • A decrease in measured GFR >= 10mL/min/1.73m2 [ Time Frame: from Month 3 to Month 12 ] [ Designated as safety issue: No ]
  • The incidence of acute rejection [ Time Frame: by 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measured GFR [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Biopsy-proven chronic allograft nephropathy [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 660
Study Start Date: March 2005
Estimated Study Completion Date: May 2015
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CsA Drug: CsA
tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months months (ST), 100-250 ng/mL, daily, 24 months (LT)
Experimental: Bela LI Drug: Belatacept 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 (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Experimental: Bela MI Drug: Belatacept 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 (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256750

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Loma Linda University Medical Center-Transplantation Institu
Loma Linda, California, United States, 92354
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
California Institute Of Renal Research
San Diego, California, United States, 92123
University Of California San Francisco Medical Center
San Francisco, California, United States, 94143
United States, Colorado
University Of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University School Of Medicine-Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Medical College Of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
University Of Chicago Hospitals
Chicago, Illinois, United States, 60637
United States, Indiana
University Of Iowa Hospitals And Clinics
Iowa City, Indiana, United States, 52242
United States, Kentucky
University Of Kentucky
Lexington, Kentucky, United States, 40536
United States, Maine
Maine Tranplant Program
Portland, Maine, United States, 04102
United States, Massachusetts
Western New England Renal & Transplant Associates, Pc
Springfield, Massachusetts, United States, 01107
United States, Michigan
Henry Ford Hospital, Transplant Institute
Detriot, Michigan, United States, 48202
United States, Minnesota
University Of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Recanati/Miller Transplantation Institute
New York, New York, United States, 10029
Columbia University College Of Physicians & Surgeons
New York, New York, United States, 10032
University Of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Div Of Multi-Organ Trans, Hepato-Biliary-Pancreatic Surgery
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
Musc
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 27232
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
Inova Transplant Center
Fairfax, Virginia, United States, 22031
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
Sacred Heart Medical Ctr Providence Medical Research Ctr
Spokane, Washington, United States, 99204
United States, Wisconsin
University Of Wisconsin
Madison, Wisconsin, United States, 53792
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, C1425APQ
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La Plata, Buenos Aires, Argentina, 1900
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Cordoba, Crd, Cordoba, Argentina, X5016KEH
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Rosario, Santa Fe, Argentina, 2000
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Buenos Aires, Argentina, C1155APP
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Santa Fe, Argentina, S3000EPV
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
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Westmead, New South Wales, Australia, 2145
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Australia, Victoria
Local Institution
Parkville, Victoria, Australia, 3052
Austria
Local Institution
Innsbuck, Austria, 6020
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Vienna, Austria, 1090
Belgium
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
Brazil
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Rio De Janeiro / Rj, Rio De Janeiro, Brazil, 21041
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035
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Porto Alegre/rs, Rio Grande Do Sul, Brazil, 90035
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Campinas, Sao Paulo, Brazil, 13033
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Sao Paulo/sp, Sao Paulo, Brazil, 04038
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Sao Paulo, Brazil, 05403
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 2S2
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Quebec
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Montreal, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H2L 2W5
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Montreal, Quebec, Canada, H1T 2M4
Canada, Saskatchewan
Local Institution
Saskatoon, Saskatchewan, Canada, S7M 0Z9
Czech Republic
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Praha 4, Czech Republic, 140 21
France
Local Institution
Bordeaux, France, 33076
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Brest Cedex, France, 29609
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Creteil, France, 94000
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Grenoble Cedex 9, France, 38043
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Nante Cedex 01, France, 44093
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Paris, France, 75015
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Toulouse, France, 31054
Germany
Local Institution
Berlin, Germany, 13353
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Erlangen, Germany, 91054
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Essen, Germany, 45122
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Hannover, Germany, 30625
Hungary
Local Institution
Szeged, Hungary, H-6720
India
Local Institution
Gujarat, Ahmedabad, India, 380016
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Nadiad, Gujarat, India, 387001
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Ahmedabad, Gujrat, India, 380052
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Cochin, Kerala, India, 682304
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Mumbai, Maharashtra, India, 400016
Local Institution
Mumbai, Maharashtra, India, 400 026
Local Institution
Chandigarh, India, 160012
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Chennai, India, 600 006
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Lucknow, India, 226000
Local Institution
New Delhi, India, 110076
Israel
Local Institution
Petah Tikva, Israel, 49100
Italy
Local Institution
Milano, Italy, 20162
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Padova, Italy, 35128
Local Institution
Roma, Italy, 00168
Mexico
Local Institution
Mexico, Distrito Federal, Mexico, 14080
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Cuernavaca, Morelos, Mexico, 62448
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Monterrey, Nuevo Leon, Mexico, 64460
Local Institution
Aguascalientes, Mexico, 20000
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Distrito Federal, Mexico, 14080
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San Luis Potosi, Mexico, 78240
Poland
Local Institution
Poznan, Poland, 60-479
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Szczecin, Poland, 70-111
South Africa
Local Institution
Observatory, Cape Town, South Africa, 7925
Local Institution
Pretoria, Gauteng, South Africa, 0002
Local Institution
Durban, Kwa Zulu Natal, South Africa, 4001
Spain
Local Institution
Barcelona, Spain, 08907
Local Institution
Madrid, Spain, 28040
Local Institution
Malaga, Spain, 29010
Sweden
Local Institution
Goteborg, Sweden, SE-413 45
Switzerland
Local Institution
Bern, Switzerland, 3010
Local Institution
Zurich, Switzerland, 8091
Turkey
Local Institution
Antalya, Turkey, 07059
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00256750     History of Changes
Obsolete Identifiers: NCT00432497
Other Study ID Numbers: IM103-008
Study First Received: November 15, 2005
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014