Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis

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

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Abatacept vs Placebo; p = 0.85; Chi-squared NCT00774852 ↗

paper There were no statistically significant differences between groups with respect to the primary outcome or any of the secondary outcomes PMID 25403681 ↗

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

Indications