Status:
COMPLETED
Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Lupus Nephritis
Lupus Erythematosus, Systemic
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
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 standar...
Detailed Description
Lupus nephritis is an inflammation of the kidney that occurs in patients with systemic lupus erythematosus (SLE). It is caused by the immune system attacking the kidney and is among the most serious c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00774852
Start Date
November 1 2008
End Date
June 1 2014
Last Update
February 8 2016
Active Locations (23)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
2
University of California San Diego
La Jolla, California, United States, 92037
3
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
4
University of California San Francisco
San Francisco, California, United States, 94143