At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Controlled, Phase II Multicenter Trial of CTLA4Ig (Abatacept) Plus Cyclophosphamide vs Cyclophosphamide Alone in the Treatment of Lupus Nephritis
In Brief
A Phase 2 clinical trial evaluating abatacept, cyclophosphamide, and 4 other interventions for Lupus Nephritis and Lupus Erythematosus, Systemic. Completed, enrolled 137 participants across 23 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Intravenous infusion (500-1000 mg, dep on weight) at weeks 0, 2, and 4, then every 4 weeks until week 24; continue to week 48 only if partial response at 24 weeks
500 mg intravenous infusion every 2 weeks for 12 weeks
2 mg/kg/day orally from weeks 12-28; continue until week 52 if only partial response observed at week 24
60 mg/day for 2 weeks, then taper to 10 mg/day by 12 weeks, then continue on stable dose
Intravenous infusion at weeks 0, 2, and 4, then every 4 weeks until week 24; continue to week 48 only if partial response at 24 weeks
Oral capsule, daily from weeks 28 to 52, only if complete response observed at week 24