Single dose of rituximab for refractory steroid-dependent nephrotic syndrome in children
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We conducted a multicenter prospective trial to evaluate the efficacy, safety and pharmacokinetics of a single dose of rituximab (375 mg/m2 body surface area) for the treatment of children with refractory steroid-dependent nephrotic syndrome (SDNS). All patients (n = 12) were able to discontinue steroids at a median of 74 days after treatment. The frequency of relapses per 6 months was significantly reduced and the steroid-free period per 6 months was significantly increased after treatment compared with those before treatment. The condition in nine of the patients (75%) relapsed at a median of 129 days after treatment, and seven patients were given additional rituximab due to steroid dependency. Most of the relapses developed simultaneously with recovery of B-cells. However, three patients (25%) did not have a relapse with B-cell recovery and the disease was kept in remission for more than 1 year. None of the patients developed life-threatening adverse events. This is the first report of a prospective study of a single dose of rituximab for refractory SDNS. Treatment with a single dose of rituximab may be effective for refractory SDNS, but its efficacy to prevent relapses was transient in most of the patients.
KeywordsRefractory steroid-dependent nephrotic syndrome Children Clinical trial Rituximab Pharmacokinetics
This study was supported by the Health and Labor Sciences Research Grant for the Large Scale Clinical Trial Network Project (to K.I.). The authors are grateful to Professor Shuki Mizutani, Department of Pediatrics and Developmental Biology, Tokyo Medical and Dental University, and the Zenyaku Corporation, for their helpful advice.
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