Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2015-12-31
2019-05-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Belatacept + Everolimus
Thymoglobulin (i.v. infusion) induction, daily (or less frequently, as tolerated) not to exceed 10 days, to reach a total cumulative dose between 3.0 and 5.5 mg/kg; belatacept (infusion) regimen of 10 mg/kg i.v. on Day 1, Weeks 1, 2, 4, 8 and 12 post transplant and then a maintenance dose of 5 mg/kg every 4 weeks after 12 weeks post transplant; everolimus (tablet) daily dosing at 3.0 mg/day, 2 divided doses, starting on Day 3 dosing adjusted based on blood sample tests; methylprednisolone (infusion) prior to each Thymoglobulin infusion and prednisone (tablet), once methylprednisolone is no longer needed. (Corticosteroids to be discontinued by Day 7 or as soon thereafter as thymoglobulin infusions are completed)
Thymoglobulin
Belatacept
Corticosteroids
Everolimus(EVL)
Tacrolimus + Mycophenolate mofetil
Thymoglobulin (i.v. infusion) induction, daily (or less frequently, as tolerated) not to exceed 10 days, to reach a total cumulative dose between 3.0 and 5.5 mg/kg; tacrolimus (tablet) daily dosing beginning at 0.1 mg/kg/day, then adjusted based on blood sample tests; MMF (tablet) daily dosing between 0.5 to 2.0 g/day divided in 2 doses (up to 3 g/day if African Americans/Blacks); methylprednisolone (infusion) prior to each Thymoglobulin infusion and prednisone (tablet), once methylprednisolone is no longer needed. (Corticosteroids to be discontinued by Day 7 or as soon thereafter as thymoglobulin infusions are completed)
Thymoglobulin
mycophenolate mofetil(MMF)
Corticosteroids
Tacrolimus(TAC)
Interventions
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Thymoglobulin
Belatacept
mycophenolate mofetil(MMF)
Corticosteroids
Everolimus(EVL)
Tacrolimus(TAC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Serologic test results are positive for past exposure to Epstein Barr Virus (EBV+)
* Diagnosed with end stage renal disease (ESRD) and scheduled to undergo transplantation of a non-HLA identical, living or standard criteria deceased donor kidney
Exclusion Criteria
* Had a previous graft loss due to acute rejection
* At increased immunologic risk of graft loss due to panel reactive antibodies (PRA) \>20% or need for desensitization therapy
* Scheduled to receive a: kidney from identical twin; or paired kidney; or kidney from a Cytomegalovirus(CMV) positive donor when recipient is CMV negative; or kidney from an extended criteria donor
* Have a body mass index (BMI) of \> 35 kg/m2 for nondiabetics or \> 30 kg/m2 for diabetics
* Diagnosed as Hepatitis B positive; or Hepatitis C positive; or HIV positive; or currently or previously active or inadequately treated latent
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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California Institute Of Renal Research
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
University Of Colorado
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Emory Univeristy
Atlanta, Georgia, United States
University Of Illinois
Chicago, Illinois, United States
Tulane Medical Center
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Erie County Medical Center
Buffalo, New York, United States
Wake Forest University School Of Medicine
Winston-Salem, North Carolina, United States
Central PA Transplant Foundation
Harrisburg, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Swedish Medical Center - Swedish Colon and Rectal Clinic - First Hill (Northwest Colon and Rectal Cl
Seattle, Washington, United States
Sanatorio Parque S.A.
Rosario, Santa Fe Province, Argentina
Clinica Privada Velez Sarsfield
Córdoba, , Argentina
Clinica De Nefrologia, Urologia Y Enf. Cardiovasculares
Sante Fe, , Argentina
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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2013-002090-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM103-177
Identifier Type: -
Identifier Source: org_study_id
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