Short-term vs Conventional Glucocorticoid Therapy for the Treatment of the Initial Episode of Adult Patient With Steroid-sensitive Idiopathic Nephrotic Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Relapse
研究概览
简要总结
This study will compare a short-term course (12 week) glucocorticoid regimen with the Conventional 24-week regimen as originally proposed by KDIGO. The purpose of the study is to determine a short-term course (12 week) of glucocorticoid decreases the time to first relapse in adults presenting with steroid sensitive nephrotic syndrome.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urine protein: creatinine ratio ≥3000mg/g (300mg/mmol)
- •Serum/plasma albumin level < 30g/L
- •Age ≥ 16 years at the time of diagnosis
- •No prior therapy with steroids, immunosuppressive or cytotoxic agents for any form of renal disease (other than the 28 days of prednisolone therapy given initially as routine clinical practice)
- •No evidence of underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome
- •Informed consent
- •SSNS defined as Complete remission within 4 weeks of prednisone or prednisolone at standard dose
排除标准
- •Secondary nephrotic syndrome
- •Contradictions for glucocorticoids
- •SRNS: Lack of complete remission within 4 weeks of therapy with daily prednisone or prednisolone at standard dose
- •anti-PLA2R positive
- •Adults with histological changes other than minimal lesion or focal segmental glomerular sclerosis (FSGS) glomerulonephritis where renal biopsy has been undertaken
- •Adults with a prior history of poor compliance with medical therapy Known allergy to glucocorticoid therapy
- •Other situations where the researcher deems it inappropriate to participate in the study
研究组 & 干预措施
conventional course prednisolone arm
干预措施: Conventional 24-week glucocorticoid regimen (Drug)
short-term course prednisolone arm
干预措施: short-term course (12 week) glucocorticoid regimen (Drug)
结局指标
主要结局
Relapse
时间窗: through study completion, an average of 2 years
Relapse of proteinuria is defined by Albustix positive proteinuria (+++ or greater) for 3 consecutive days or the presence of generalised oedema plus 3+ proteinuria.
次要结局
- Relapse rate(12 months，24 months)
研究者
Tianxin Chen
Principal Investigator
First Affiliated Hospital of Wenzhou Medical University