Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Lupus Nephritis, Lupus Erythematosus, Systemic

In brief

This study is for individuals with lupus who have developed complications in their kidneys, or lupus nephritis. The study will determine whether adding the experimental medication abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis than standard cyclophosphamide therapy by itself.

Key facts

Study ID

NCT00774852

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

137

Starts

2008-11-01

Expected to finish

2014-06-01

Last updated by the study team

2016-02-08

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology (ACR) criteria
• Active lupus nephritis (defined by: kidney biopsy documentation within the last 12 months using International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification- proliferative nephritis, active urinary sediment, urine protein-to-creatinine ratio > 1, low complement C3)
• Positive antinuclear antibody (ANA) test result at time of study entry

You may not qualify if…

• End stage renal disease
• Use of cyclophosphamide in the past year
• Neutropenia, thrombocytopenia, moderately severe anemia
• Active infection, including HIV, hepatitis B or C
• History of cancer, except carcinoma in situ and treated basal and squamous cell carcinomas
• Pregnant or breastfeeding

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• University of California San Diego — La Jolla, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• Feinstein Institute — Manhasset, New York, United States
• Seligman Center for Advanced Therapeutics (NYU) — New York, New York, United States
• Columbia University — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• UNC Chapel Hill — Chapel Hill, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States
• Temple University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Lupus Center of Excellence — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• UT Southwestern — Dallas, Texas, United States
• Unidad de investigación en enfermedades crónico - degenerativas SC — Guadalajara, Jalisco, Mexico
• El Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INNSZ) — Mexico City, Mexico

Full record on ClinicalTrials.gov

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