Comparative Study of 3 or 6 Months Initial Steroid Treatment in Children Under 6 Years of Age With Steroid Sensitive Nephrotic Syndrome：a Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment
研究概览
简要总结
This study is a multicentric, prospective, randomized, double blind, placebo controlled trial compared the efficacy of 6 months vs. 3 months of initial prednisolone therapy in decreasing the incidence of FRNS with steroid-sensitive nephrotic syndrome in children age 1 year up to 6 years. Three months tapering prednisolone or placebo are administrated follow by open-label 3 months standard prednisolone therapy.The cumulative incidence of FRNS and adverse events for one year were evaluated in the 3-month and 6-month groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic, steroid-sensitive, first episode of nephrotic syndrome
- •Age 12 months up to 6 years
- •Written informed consent
排除标准
- •Nephrotic syndrome known to be secondary to a systemic disorder, e.g., Immunoglobulin A (IgA) nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, , hepatitis B or Alport syndrome.
- •Therapy with prednisolone for prior episodes of nephrotic syndrome
- •Persistent estimated glomerular filtration rate (GFR) <75 ml/min/1.73 m2
- •Patients who show relapse during the first 3 months of pre-randomization corticosteroid therapy for nephrotic syndrome
- •Patients with initial steroid resistance
- •Patients who are allergic to glucocorticoids
- •The compliance of patients or their guardians is poor
研究组 & 干预措施
3 months group
Subjects will receive 12-weeks of placebo following randomization
干预措施: Placebo (Drug)
6 months group
12 Weeks of Prednisolone Therapy Subjects will add an additional 12 weeks of Prednisolone to follow pre-randomization standard of care prednisolone.
干预措施: Prednisolone (Drug)
结局指标
主要结局
Occurrence of frequent relapses of nephrotic syndrome at 12th month after 3 month standard treatment
时间窗: 12 month period after 3 month standard treatment
Proportion of patients with frequent relapses at 12th month after 3 month standard treatment.Frequent relapses nephrotic syndrome was defined as two or more relapses within 6 months after completing initial treatment, or four relapses within any period of 12 months, including relapses during initial treatment.
次要结局
- The use of steroid-sparing medications(12 month period after 3 month standard treatment)
- Adverse events during 12-month period after 3 month standard treatment(12 month period after 3 month standard treatment)
- Change in height during 12-month period after 3 month standard treatment(12 month period after 3 month standard treatment)
- Number of relapses during 12 months follow up after 3 month standard treatment(12 month period after 3 month standard treatment)
- Time to first relapse (days)(12 month period after 3 month standard treatment)
- Cumulative prednisolone [or corticosteroid equivalent] received during 12 month period after 3 month standard treatment(12 month period after 3 month standard treatment)
- Occurrence of steroid-dependent nephrotic syndrome at 12th month after 3 month standard treatment(12 month period after 3 month standard treatment)