drugset / Trial / NCT01861561

Low-dose VS High-dose IV Cyclophosphamide for Proliferative LN in Children

NCT01861561

Phase 4 Terminated 43 enrolled Mahidol University
RandomizedParallel-groupOpen-labelTreatment

Summary

Proliferative lupus nephritis (LN)is the predominant cause of morbidity and mortality in juvenile Systemic Lupus Erythematosus (SLE). Induction therapy with high-dose intravenous cyclophosphamide can improve renal outcomes, but considerably associated with infection. Although severe infection is the significant complication related to poorer prognosis for juvenile SLE patients in Asia, cyclophosphamide is still commonly used as the drug of choice for severe lupus nephritis. Euro-Lupus Nephritis Trial demonstrated low-dose intravenous cyclophosphamide regimen followed by azathioprine achieved good clinical results comparable with obtained high-dose regimen. There was lower number of severe infection episodes, but no significant difference. Recent studies applied low dose of cyclophosphamide (500 mg/m2/dose or 500 mg/dose)in young patients and showed good renal response. Low-dose intravenous cyclophosphamide regimen might promote non-inferior renal remission whereas decrease risk of serious infection and improve overall patient outcomes.

Timeline

Start
2013-05
Primary completion
2019-05
Completion
2019-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 1000 mg/m2 Intravenous