Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Lupus Nephritis

In brief

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)

Key facts

Study ID

NCT01714817

Run by

Bristol-Myers Squibb

People needed

695

Starts

2013-01-22

Expected to finish

2018-05-30

Last updated by the study team

2021-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Valerius Med Group & Res Ctr Of Greater Long Beach, Inc. — Long Beach, California, United States
• East Bay Rheumatology Medical Group, Inc. — San Leandro, California, United States
• University Of Connecticut Health Center — Farmington, Connecticut, United States
• University Of Miami Miller School Of Medicine — Miami, Florida, United States
• Integral Rheumatology & Immunology Specialists — Plantation, Florida, United States
• Emory University. — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Ochsner Clinic Foundation — Baton Rouge, Louisiana, United States
• Tulane University School Of Medicine — New Orleans, Louisiana, United States
• Brigham & Women'S Hospital — Boston, Massachusetts, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Local Institution — Camden, New Jersey, United States
• Suny Downstate Medical Center — Brooklyn, New York, United States
• Northshore Lij Health System — Great Neck, New York, United States
• The Feinstein Institute For Medical Research — Manhasset, New York, United States
• Hospital For Special Surgery — New York, New York, United States
• Local Institution — New York, New York, United States
• University Of North Carolina At Chapel Hill — Chapel Hill, North Carolina, United States
• Shanahan Rheum & Immunotherapy, PLLC — Raleigh, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Paramount Medical Research & Consulting, Llc — Middleburg Heights, Ohio, United States
• Rheumatology Consultants Pllc — Knoxville, Tennessee, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• University Of Utah Hospital — Salt Lake City, Utah, United States
• University Of Alabama At Birmingham (Uab) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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