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临床试验/NCT00863252
NCT00863252已完成4 期

A Prospective, Randomized, Open Label, Case-Controlled Study on the Efficacy of Mycophenolate Mofetil for IgA Nephropathy Patients With Heavy Proteinuria Despite Angiotensin Blockade

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2002年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
40
试验地点
1
主要终点
24 hour urinary protein excretion

研究概览

简要总结

IgA nephropathy (IgAN) is the commonest primary glomerulonephritis worldwide. In Hong Kong, IgAN accounts for approximately 30% of all primary glomerular diseases, and a significant proportion of young patients (< 50 years of age) on dialysis therapy are sufferers of primary IgAN. To date, no specific therapeutic agent has been consistently shown to halt the progression of IgAN to end-stage renal failure, particularly in patients with persistent significant proteinuria and the presence of chronic tubulointerstitial inflammation on kidney biopsy. In recent years, angiotensin-converting enzyme inhibitors (ACEI) have been found capable of significantly reducing proteinuria in some IgAN patients, while others, particularly those with the ACE DD genotype, showed either absent or unsatisfactory response to angiotensin blockade. Mycophenolate mofetil (MMF) is a marketed immunosuppressive drug which acts by releasing mycophenolic acid (MPA) to inhibit the de novo pathway of purine synthesis, and hence is relatively selective for lymphocytes. Apart from being efficacious for the prophylaxis of renal allograft rejection and for the induction of remission in severe lupus nephritis, MMF has been anecdotally reported to avert progression to allograft failure in recurrent IgAN of the transplanted kidney. Data on the clinical efficacy of MMF in the treatment of primary IgAN, however, is lacking. In the current proposal, we aim to study the clinical efficacy of MMF in patients with biopsy-proven IgAN and clinically significant proteinuria despite angiotensin blockade. Patients will be followed up for at least 5 years to track any survival difference between groups.

详细描述

(i) STUDY DESIGN

This will be a prospective, randomized, open-label, case-controlled study. Patients of either gender with biopsy-proven IgAN and clinically significant proteinuria despite being on ACEI treatment will be potential candidates (see selection criteria). Eligible patients will be randomized into either of the following groups:

Group I (Intervention arm):

Patients will be given MMF at a daily dose of 1.5 g orally in 2 divided doses in addition to concurrent medications, including ACEI. Duration of therapy is expected to be six months.

Group II (Control arm):

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
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females between the ages of 18 and 70 years
  • Renal biopsy showing a histological diagnosis IgAN, with predominant or codominant mesangial deposition of IgA on immunofluorescent studies
  • Daily urinary protein excretion > 1 g on at least 3 separate occasions
  • Serum creatinine < 400 umol/L
  • Patients who are willing to give written informed consent and to participate in and comply with the study protocol

排除标准

  • Presence of concomitant glomerular diseases
  • Patients with known hypersensitivity to MMF
  • Patients receiving treatment with other cytotoxic agents
  • Serum creatinine > 400 umol/L
  • Women who are lactating, pregnant or of childbearing potential not using, or who are unwilling to use, a reliable contraceptive method during and for 6 weeks following conclusion of MMF therapy. A pregnancy test to exclude pregnancy will be performed for women of childbearing potential prior to recruitment
  • Patients who are unable or unwilling to give written informed consent and to participate in and comply with the study protocol
  • Presence of systemic infection or malignancy requiring therapy at the time of entry to the study
  • Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study

研究组 & 干预措施

1

Experimental

MMF

干预措施: mycophenolate mofetil (Drug)

2

Active Comparator

Control

干预措施: angiotensin blockade (Drug)

结局指标

主要结局

24 hour urinary protein excretion

时间窗: 18 months to 5 years

次要结局

  • Renal survival Serum creatinine level and creatinine clearance Urine albumin-to-creatinine ratio(at least 5 years)

研究者

申办方类型
Other

研究点 (1)

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