Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis



Status:Completed
Conditions:Lupus, Nephrology
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:8/30/2018
Start Date:January 22, 2013
End Date:May 30, 2018

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A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil and Corticosteroids in the Treatment of Subjects With Active Class III or IV Lupus Nephritis

The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when
used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)


For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching
Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on
clinical trial participation.

Note: Subjects > 16 are eligible for enrollment at selected centers

Inclusion Criteria:

- Potential subjects must have active lupus nephritis

- Biopsy within 12 months prior to screening visit indicating active Class 3 or 4
proliferative lupus glomerulonephritis (lupus effecting your kidney)

- Urine protein creatinine ratio (UPCR) ≥ 1 at Screening

- Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L)

- There must also be evidence of active disease within 3 months of Screening, based on
at least one of the following:

- Worsening of lupus nephritis OR

- UPCR ≥ 3 at Screening OR

- Active urine sediment OR

- Biopsy within 3 months prior to screening visit indicating active Class 3 or
Class 4 active proliferative lupus glomerulonephritis

Inclusion Criteria for the Long-Term Extension Period:

- Signed Written Informed Consent

- Subjects who achieve a complete or partial renal response after completing 2 years of
double-blind treatment

Exclusion Criteria:

- Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis

- Current symptoms of severe, progressive, or uncontrolled non-SLE related renal,
hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or
cerebral disease, or other concomitant medical conditions that, in the opinion of the
Investigator, might place the subject at unacceptable risk for participation in this
study

- Significant active Central nervous system (CNS) lupus with the exception of fatigue or
mild stable cognitive

- Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too
significant and irreversible
We found this trial at
27
sites
263 Farmington Ave
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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Brooklyn, NY
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Baton Rouge, Louisiana 70809
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Birmingham, Alabama 35294
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1 Boston Medical Center Place
Boston, Massachusetts 02118
617.638.8000
Boston University Medical Center Boston Medical Center is an extraordinary community of health care providers...
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Boston, MA
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Camden, New Jersey 08103
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Capital Federal, Buenos Aires
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Charlottesville, Virginia 22908
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Cleveland, OH
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2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Great Neck, New York 11021
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Knoxville, Tennessee 37909
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Middleburg Heights, Ohio 44130
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New Orleans, Louisiana 70112
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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New York, New York 10016
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Plantation, FL
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Raleigh, North Carolina 27617
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Salt Lake City, Utah 84132
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San Leandro, California 94578
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