Trial record 1 of 1 for:    NCT00114777
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Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant (BENEFIT-EXT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00114777
First received: June 17, 2005
Last updated: August 11, 2014
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Renal Transplantation
Drug: CsA
Drug: Belatacept LI
Drug: Belatacept MI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety 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 - Extended Criteria Donors (BENEFIT-EXT)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • subject and graft survival [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • measured GFR and measured GFR change from baseline [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • biopsy proven chronic allograft nephropathy [ Time Frame: by 12 months ] [ Designated as safety issue: No ]
  • post-transplant diabetes mellitus, hypertension and dyslipidemia [ Time Frame: at 12, 24 and 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2005
Estimated Study Completion Date: November 2014
Primary Completion Date: May 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 (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 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:

  • 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)
  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: NCT00114777

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, California
National Institute Of Transplantation
Los Angeles, California, United States, 90057
Ucla Kidney & Kidney-Pancreas Transplant Research Office
Los Angeles, California, United States, 90024
Sharp Memorial Hospital
San Diego, California, United States, 92133
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
New Haven, Connecticut, United States, 06540
United States, Florida
Lifelink Healthcare Institute
Tampa, Florida, United States, 33606
United States, Georgia
Piedmont Transplant Institute
Atlanta, Georgia, United States, 30309
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
University Of Chicago Hospitals
Chicago, Illinois, United States, 60637
Northwestern University-Feinberg School Of Medicine
Chicago, Illinois, United States, 60611
United States, Louisiana
Acadiana Renal Physicians
New Iberia, Louisiana, United States, 70563
Tulane Abdominal Transplant Institute
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
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
Columbia University College Of Physicians & Surgeons
New York, New York, United States, 10032
Mount Sinai School Of Medicine
New York, New York, United States, 10029
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
United States, Pennsylvania
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Drexel University College Of Medicine, Department Of Surgery
Philadelphia, Pennsylvania, United States, 19102
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Wisconsin
University Of Wisconsin
Madison, Wisconsin, United States, 53792
Froedtert Memorial Hospital
Milwaukee, Wisconsin, United States, 53226
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, C1155APP
Local Institution
Capital Federal, Buenos Aires, Argentina, 1425
Local Institution
Cordoba, Crd, Cordoba, Argentina, X5016KEH
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Rosario, Santa Fe, Argentina, 2000
Local Institution
Santa Fe, Argentina, S3000EPV
Australia, South Australia
Local Institution
Woodville, South Australia, Australia, 5011
Austria
Local Institution
Innsbuck, Austria, 6020
Local Institution
Vienna, Austria, 1090
Belgium
Local Institution
Leuven, Belgium, 3000
Brazil
Local Institution
Porto Alegre, Rio Grande Do Sul, Brazil, 90035
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Porto Alegre/rs, Rio Grande Do Sul, Brazil, 90035
Local Institution
Campinas/sp, Sao Paulo, Brazil, 13083
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Rio De Janeiro, Brazil, 21041
Local Institution
Sao Paulo, Brazil, 4038-002
Local Institution
Sao Paulo, Brazil, 05403
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 2S2
Canada, Nova Scotia
Local Institution
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H3A 1A1
Canada, Saskatchewan
Local Institution
Saskatoon, Saskatchewan, Canada, S7M 0Z9
Chile
Local Institution
Santiago, Metropolitana, Chile
Czech Republic
Local Institution
Prague 4, Czech Republic, 140 21
France
Local Institution
Bordeaux, France, 33076
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Brest, Cedex 29, France, 29609
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Creteil, France, 94000
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Le Kremlin Bicetre Cedex, France, 94275
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Nante Cedex 01, France, 44093
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Paris, France, 75015
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Toulouse Cedex, France, 31054
Local Institution
Tours Cedex 09, France, 37044
Local Institution
Vandoeuvre Les Nancy Cedex, France, 54511
Germany
Local Institution
Berlin, Germany, 10117
Local Institution
Berlin, Germany, 13353
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Erlangen, Germany, 91054
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Essen, Germany, 45147
Local Institution
Hannover, Germany, 30625
Hungary
Local Institution
Budapest, Hungary, 1082
Local Institution
Szeged, Hungary, H-6720
Italy
Local Institution
Milano, Italy, 20162
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Padova, Italy, 35128
Local Institution
Roma, Italy, 00168
Norway
Local Institution
Oslo, Norway, N-0027
Poland
Local Institution
Poznan, Poland, 60-479
Local Institution
Warszawa, Poland, 02-006
South Africa
Local Institution
Pretoria, Gauteng, South Africa, 0181
Spain
Local Institution
Barcelona, Spain, 08036
Local Institution
Barcelona, Spain, 08907
Local Institution
Madrid, Spain, 28040
Local Institution
Madrid, Spain, 28041
Local Institution
Malaga, Spain, 29010
Sweden
Local Institution
Gothenburg, Sweden, 413 45
United Kingdom
Local Institution
Manchester, United Kingdom, M13 9WL
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: NCT00114777     History of Changes
Other Study ID Numbers: IM103-027
Study First Received: June 17, 2005
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014