JPRN-jRCTs071180060已完成3 期
High-dose mizoribine with prednisolone therapy in short-term relapsing steroid-sensitive nephrotic syndrome to prevent frequent relapse - JSKDC05 trial
akanishi Koichi0 个研究点目标入组 88 人开始时间: 2019年3月19日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
研究概览
简要总结
Overall, the results of the mizoribine combination were better than those of the standard treatment group, confirming its efficacy. Infections occurred more frequently in the high-dose mizoribine group, but there were no deaths or serious adverse events, and safety was acceptable.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 2age old 至 < 11age old（—）
- 性别
- All
入选标准
- •(1) Patients diagnosed with a first episode of nephrotic syndrome who meet 1) urinary protein/creatinine ratio > or = 1.8 and 2) < or = 2.5 g/dL of serum albumin
- •(2) Patients treated by the ISKDC based regimen at the first episode and relapsed within 6 months after the first remission
- •(3) Age at the registration > or = 2 and < 11 years
- •(4) Patients who remit within 3 weeks after PSL treatment for the first relapse
排除标准
- •(1) Patients diagnosed with nephritic nephrotic syndrome
- •(2) Patients diagnosed with IgA vasculitis, systemic lupus nephritis or secondary nephrotic syndrome
- •(3) Patients who have been diagnosed with steroid-resistant nephrotic syndrome (SRNS)
- •(4) Patients who have been treated with any immunosuppressant for nephrotic syndrome
- •(5) Patients with poorly controlled hypertension, impaired renal function, or severe liver dysfunction
- •6) Patients who are participating in other studies at the time of registration
研究者
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