Regimen Optimization Study



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:12/8/2018
Start Date:December 31, 2015
End Date:November 6, 2019

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Evaluation of Acute Rejection Rates in de Novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (Belatacept)-Based Immunosuppression

Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress
the immune system (called immunosuppressive regimens) to stop the immune system from
attacking the transplanted kidney in order to limit damage to or the possibility of rejecting
the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two
immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate
mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.

Calcineurin inhibitor (CNI)

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Men and women, aged 18 to 75

- 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:

- Primary cause of ESRD is: primary focal segmental glomerulosclerosis; or Type I or II
membranoproliferative glomerulonephritis; or Hemolytic Uremic Syndrome / Thrombotic
Thrombocytopenic Purpura

- 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
We found this trial at
18
sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Phone: 404-712-1787
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-4087
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Boston, MA
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Phone: 703-776-8085
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Falls Church, VA
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-936-1182
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Aurora, Colorado 80045
Phone: 303-724-0342
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Buffalo, New York 14215
Phone: 716-898-4724
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Buffalo, NY
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Phone: 434-924-5529
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Charlottesville, VA
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Phone: 312-413-7370
Univ of Illinois A major research university in the heart of one of the world's...
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Chicago, IL
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984 Avenida Naciones Unidas
Cordoba,
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Cordoba,
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Harrisburg, Pennsylvania 17104
Phone: 717-231-8765
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Harrisburg, PA
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Phone: 973-322-8892
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Livingston, NJ
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Phone: 203-737-7683
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Orleans, Louisiana 70112
Phone: 504-988-5272
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San Diego, California 92123
Phone: 858-637-4600
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San Diego, CA
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
Phone: 415-600-1744
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Phone: 206-386-3332
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Washington, District of Columbia 20007
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Winston-Salem, North Carolina 26157
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