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临床试验/NCT00301613
NCT00301613已完成不适用

MMF Versus Intravenous CTX Pulses in the Treatment of Adult Severe Henoch-Schonlein Purpura Nephritis

Nanjing University School of Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2003年1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
60
试验地点
1
主要终点
To compare the efficacy,safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN

研究概览

简要总结

This study is performed to compare the efficacy, safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN

详细描述

Henoch-Schoenlein purpura nephritis (HSPN) with massive proteinuria,renal insufficiency and crescent formation at onset have high risks of progressing to end stage renal failure. Though clinical studies have shown that steroids in combination with cyclophosphamide could reduce proteinuria and preserve renal function, this protocol is associated with many side effects, and is not effective in some patients.

Recent studies have shown that mycophenolic acid(MPA), the active metabolite of mycophenolate mofetil(MMF),could inhibit multifarious effects on endothelial cells, including adhesion molecular expression, neutrophil attachment,IL-6 secretion, and the process of angiogenesis, which contribute to the efficacy of MMF in the treatment of vasculitis. Clinical studies also showed that MMF was effective in the treatment of lupus nephritis with vasculitic lesions. These findings suggest that MMF might be effective in the treatment of severe HSPN, which is a kind of vasculitic lesion. This prospective open-labeled clinical trial study investigates the efficiency of MMF in the treatment of severe HSPN compared with pulse intravenous cyclophosphamide. After 12 months of treatment, we will assess the efficacy, safety, tolerability and relapse of MMF compared with cyclophosphamide in the treatment of severe HSPN.

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
16 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 16-50 years
  • Biopsy proved HSP
  • Proteinuria ≥ 3.0 g/24hr
  • Scr < 5.0 mg/dl

排除标准

  • Cytotoxic drug treatment such as CTX, CsA, MMF for morn than 1 month-3 months prior to enrolled
  • Pregnancy
  • Active/serious infections
  • Previous diagnosed diabetes mellitus type 1 or 2

研究组 & 干预措施

Mycophenolate mofetil

Active Comparator

干预措施: Mycophenolate mofetil (Drug)

结局指标

主要结局

To compare the efficacy,safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
Nanjing University School of Medicine
申办方类型
Other

研究点 (1)

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