drugset / Trial / NCT00774852
Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis
Phase 2
Completed
137 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN) · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2008-11
- Primary completion
- 2012-12
- Completion
- 2014-06
Publications
- Results ACCESS Trial Group. Treatment of lupus nephritis with abatacept: the Abatacept and Cyclophosphamide Combination Efficacy and Safety Study. Arthritis Rheumatol. 2014 Nov;66(11):3096-104. doi: 10.1002/art.38790.
- Results Wofsy D, Diamond B, Houssiau FA. Crossing the Atlantic: the Euro-Lupus Nephritis regimen in North America. Arthritis Rheumatol. 2015 May;67(5):1144-6. doi: 10.1002/art.39067. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abatacept | Other / unclassified | 500 mg | Intravenous |
| Subject | Abatacept | Other / unclassified | 1000 mg | Intravenous |
| Background | Azathioprine | Small molecule | 2 mg/kg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 500 mg | Intravenous |
| Background | Prednisone | Other / unclassified | 10 mg | Oral |