A Prospective Observational Study to Assess the Efficacy an Safety of Glucocorticoid Therapy in the Treatment of Adult Idiopathic Nephrotic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- the cumulative complete remission rate of 8-weeks full-dose induction protocol
研究概览
简要总结
This study is to assess the efficacy and safety of 8-weeks full-dose induction protocol (prednisone 1mg/kg, maximum 60mg/day) and protracted tapering protocol in the treatment of adult idiopathic nephrotic syndrome.
详细描述
In full-dose induction period, patients scheme to visit at the 4th and 8th week, and in protracted tapering period at 10th , 22nd, 42nd and 66th week. If the patients reach complete remission within 4 weeks, prednisone may be decreased at the 6th week, otherwise keep on the course to the 8th week. All patients reach complete remission will shift to protracted tapering period and follow up until prednisone withdrawal, except the cases that relapse and drop out the study. If proteinuria reappears in someone, angiotensin-converting enzyme inhibitor（ACEI） or angiotensin receptor blocker（ARB） will be considered combination, on the premise of the blood pressure is affordable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who signed written informed consent form
- •Age between 18-65 years, female or male
- •Patients with diagnosis of nephrotic syndrome ( proteinuria ≥3.5 g/24h, and serum albumin ≤30g/L ),
- •Pathological diagnosis with minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS) and podocyte disease
- •Serum creatinine < 3mg/dl ( 265.2umol/L), estimated glomerular filtration rate(eGFR) no less than 30 ml/min.1.73 m2
排除标准
- •Patients who didn't sign written informed consent form
- •Patients who have received full-dose prednisone treatment for more than 2 weeks, or pulsed methylprednisolone (>7.5mg/kg.day) within 2 weeks
- •Patients who have taken immunosuppressants within 3 months, as Cyclosporine A, Tacrolimus, Mycophenolate Mofetil, Cyclophosphamide, or Leflunomide etc.
- •Patients who have impaired liver function, with Alanine aminotransferase(ALT) or Aspartate aminotransferase(AST) twice more than the normal upper limit, or who have viral hepatitis B with hepatitis B e antigen(HBeAg) positive or hepatitis B virus DNA (HBV-DNA) reduplicative
- •Patients who have contraindications to glucocorticoid, for example diabetes, obesity (BMI>28kg/m2 before disease onset), femoral head necrosis, or active infection.
- •Patients who have family history of kidney disease
- •Patients who have definite secondary facts of this disease.
研究组 & 干预措施
prednisone
First,full-dose induction period, then protracted tapering period.
干预措施: prednisone (Drug)
结局指标
主要结局
the cumulative complete remission rate of 8-weeks full-dose induction protocol
时间窗: 8 weeks
次要结局
- the relapse rate of complete remission participants protracted tapering protocol(66 weeks)
研究者
Zhi-Hong Liu, MD
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing University School of Medicine