Journal
PEDIATRIC NEPHROLOGY
Volume 24, Issue 7, Pages 1321-1328Publisher
SPRINGER
DOI: 10.1007/s00467-009-1191-0
Keywords
Refractory steroid-dependent nephrotic syndrome; Children; Clinical trial; Rituximab; Pharmacokinetics
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Funding
- Health and Labor Sciences Research Grant for the Large Scale Clinical Trial Network Project
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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/m(2) 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.
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