跳至主要内容
临床试验/NCT00301600
NCT00301600已完成不适用

Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy

Nanjing University School of Medicine1 个研究点 分布在 1 个国家目标入组 40 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
40
试验地点
1
主要终点
To compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy

研究概览

简要总结

A single-center random parallel study to compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy

详细描述

IgA nephropathy is an immune-complex glomerulopathy that can result in capillary necrosis or extracapillary proliferation (crescents). Several studies have documented a higher incidence of hypertension and nephritic-range proteinuria in patients with the crescentic form of IgA nephropathy, suggesting that patients with this variant of the disease may have a worse prognosis. Some studies have shown that treatment with steroids and cyclophosphamide had efficacy on reducing proteinuria and preserving renal function by healing vasculitic lesions, therefore preventing the progression of glomerular sclerosis. Recent studies have also shown that mycophenolate mofetil is effective in the treatment of lupus nephritis with vasculitic lesion and small vasculitis with renal involvement. We will conduct a single-center prospective open-labeled clinical trial of 40 patients with crescentic IgA nephropathy and treat them randomly with pulse intravenous cyclophosphamide or oral mycophenolate mofetil. After 12 months of treatment, we will assess the efficacy, safety, tolerability and relapse of mycophenolate mofetil compared with cyclophosphamide in the treatment of crescentic IgA nephropathy.

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
12 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with a diagnosis of IgAN without deposition of C4 and C1q, age 10-70y, sex free
  • Gross hematuria or an active urine sediment
  • Segmental necrotizing lesion of the capillary wall
  • Cellular or fibrocellular crescents ≥ 10%
  • Fibrinoid degeneration of small vessels
  • Fibrin positive Three or more items, with provision of criteria informed consent

排除标准

  • More than four-week treatment with cytotoxic drug, such as CTX, CsA and MMF, prior to enrollment
  • Immune deficiency
  • Serum creatinine ≥ 5.0mg/dl
  • Previous malignancy
  • Diabetic mellitus or obesity
  • Severe infection or CVS complications
  • Henoch-Schonlein purpura nephritis, systemic vasculitis, SLE

研究组 & 干预措施

Mycophenolate mofeti

Active Comparator

干预措施: Mycophenolate mofetil (Drug)

结局指标

主要结局

To compare the efficacy and safety of Mycophenolate mofetil versus intravenous Cyclophosphamide pulses in the treatment of crescentic IgA nephropathy

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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