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临床试验/NCT01451710
NCT01451710已完成不适用

The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy

Nanjing University School of Medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
24h urinary protein excretion

研究概览

简要总结

This is a single center,prospective,no-controlled clinical trial

详细描述

  1. The complete remission of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients
  2. The safety of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients

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

入选标准

  • Female or male patients aged between 18 to 65 years
  • Renal biopsy was used to diagnose IgA nephropathy
  • Patients with 24h proteinuria 3.5g and serum albumin concentration lower than 30g/L

排除标准

  • Patients with serum creatinine ≥ 3 mg/dl or eGFR < 30ml/min per 1.73 m2
  • urine RBC > 1 million/ml
  • Patients who have received treatment of enough steroids for more than 12 weeks
  • patients with secondary IgA
  • Patients who have impaired liver function,with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis
  • Patients with 2 type diabetes or obesity, whose BMI is more than 28kg/m2

研究组 & 干预措施

Prednisone or Prednisolone

Experimental

干预措施: Prednisone or Prednisolone (Drug)

结局指标

主要结局

24h urinary protein excretion

时间窗: 3 months

次要结局

  • remission rate(3 months)

研究者

发起方
Nanjing University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhi-Hong Liu, M.D.

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Nanjing University School of Medicine

研究点 (1)

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