Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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 standard cyclophosphamide therapy is more effective in improving lupus nephritis than standard cyclophosphamide therapy by itself.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Immune Tolerance Network (ITN)
• Treatments: Abatacept; Azathioprine; Cyclophosphamide; Prednisone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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