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临床试验/NCT02173106
NCT02173106Unknown2 期

Opportunity, Validity and Security of Steroids Plus Cyclosporin Therapy for Patients of Idiopathic Membranous Nephropathy : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial

Sun Yat-sen University6 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
180
试验地点
6
主要终点
Remission of proteinuria (complete or partial)

研究概览

简要总结

This prospective, randomized, controlled, multicenter clinical trial will evaluate Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of Idiopathic Membranous Nephropathy.

详细描述

Idiopathic membranous nephropathy is a main reason for nephropathy. Since it can get spontaneous remission, in KDIGO, it is recommend that initial therapy should be started only in patients with nephrotic syndrome and when at least the following condition is met:urinary protein excretion persistently exceeds 4g/d and remains at over 50% of the baseline value,and does not show progressive and antiproteinuric therapy during an observation period of at least 6 months. But many retrospective researches reported that using steroids and immunosuppressive agents were better than waiting for spontaneous remission. There were few prospective, randomized, controlled research on whether it is better that begin to use steroids and immunosuppressive agent early without waiting for 6 months. In our study,we evaluate the validity and security of steroids plus cyclosporin therapy in idiopathic membranous nephropathy. This will be a prospective, randomized, controlled, multicenter study. Patients in treatment group will receive oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. Patients in control group will waiting for spontaneous remission for 6 months,if there were no spontaneous remissions, patients in control group will receive oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. After followed-up for 6 months the curative and side effect of steroid plus cyclosporin therapy in the early stage of idiopathic membranous nephropathy will be evaluated.

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
None

入排标准

年龄范围
14 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 14~75 years, regardless of gender without secondary reason, idiopathic membranous nephropathy by renal biopsy
  • Average urinary protein excretion of at least3.5g/24h on two successive examinations,or plasma albumin <30g/l
  • eGFR≥40ml/min/1.73m2
  • Willingness to sign an informed consent

排除标准

  • Secondary membranous nephropathy such as systemic lupus erythematosus, hepatitis B -associated nephritis
  • Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
  • Cirrhosis, chronic active liver disease
  • History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease)
  • Any Active systemic infection or history of serious infection within one month.
  • Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure, chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases)
  • Active tuberculosis
  • Known allergy, contraindication or intolerance to the steroids
  • Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception
  • Malignant tumors
  • Excessive drinking or drug abuse
  • Mental aberrations
  • Current or recent (within 30 days) exposure to any other investigational drugs

研究组 & 干预措施

Group A: steroid & Cyclosporin

Experimental

oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months.

干预措施: steroid & Cyclosporin (Drug)

结局指标

主要结局

Remission of proteinuria (complete or partial)

时间窗: up to 6 months

次要结局

  • Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation).(up to 6 months)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanhong Deng

The Sixth Affiliated Hospital of Sun Yat-Sen University

Sun Yat-sen University

研究点 (6)

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