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临床试验/NCT00755859
NCT00755859已完成4 期

Corticosteroids and Azathioprine Versus Corticosteroids Alone in IgA Nephropathy: a Randomized Controlled Trial.

A. Manzoni Hospital28 个研究点 分布在 2 个国家目标入组 206 人开始时间: 1998年5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
发起方
入组人数
206
试验地点
28
主要终点
progression of renal disease, estimated by the time to 50% increase in plasma creatinine from baseline.

研究概览

简要总结

In a previous trial the investigators found that the effect of steroids in IgA nephropathy diminish over time. The difference in renal survival is striking up till the third year, but then remains constant. A six-month course of steroid therapy may be not enough to ensure a stable remission. The investigators hypothesized that a more aggressive treatment may obtain long-term better results. The investigators conducted a randomised controlled trial to assess the utility of low-dose azathioprine added to steroids in adult IgAN patients.

详细描述

In 1999, we published a multicenter, randomized, controlled trial, which compared a 6-month steroid course with supportive therapy in 86 patients with IgAN. After 5 years of follow-up, the risk of a 50% increase in plasma creatinine from baseline was significantly lower in the treated patients; proteinuria also decreased. However, the effect of steroids seemed to diminish over time. The difference in renal survival was particularly striking up till the third year, but then remained constant. We hypothesised that a six-month course of steroid therapy is not enough to ensure a stable remission, and a more aggressive treatment may be required to obtain long-term better results. At this regard, some studies of combined treatment with corticosteroids and azathioprine found that treatment was effective in preserving renal function and in reducing proteinuria. However, these studies did not clarify whether azathioprine added further benefit to steroids in the long term. We conducted a randomised controlled trial to assess the utility of low-dose azathioprine added to steroids in adult IgAN patients.

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

入选标准

  • biopsy proven IgA nephropathy
  • creatinine ≤ 2.0 mg/dl for at least three months
  • proteinuria ≥ 1.0 g/day for at least three months

排除标准

  • treatment with steroids or cytotoxic drugs during the previous three years
  • contraindications to steroids or azathioprine
  • Henoch-Schöenlein purpura
  • diabetes mellitus
  • severe hypertension (diastolic blood pressure > 120 mmHg)
  • lupus erythematosus systemicus
  • malignancies
  • active peptic-ulcer disease
  • pregnancy
  • viral hepatitis or other infections

研究组 & 干预措施

1

Experimental

Six month steroid course plus azathioprine

干预措施: steroids plus azathioprine (Drug)

2

Active Comparator

six month steroid course

干预措施: steroids (Drug)

结局指标

主要结局

progression of renal disease, estimated by the time to 50% increase in plasma creatinine from baseline.

时间窗: Every month for the first six months, then six months

次要结局

  • evolution of proteinuria over time(every months for the first six months and then every six months)
  • safety(every months for the first six months and then every six months)

研究者

发起方
A. Manzoni Hospital
申办方类型
Other

研究点 (28)

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