ISRCTN03001669已完成不适用
European Community SYStemic VASculitis TRIALs group
Addenbrookes Hospital NHS Trust (UK)0 个研究点目标入组 150 人开始时间: 2006年2月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. New diagnosis of Wegener granulomatosis (WG), micropolyarteritis (MP) or its renal-limited variant, in accordance with the Chapel Hill Consensus criteria, with active vasculitis, as indicated by the presence of active necrotising glomerulonephritis on renal biopsy
- •2. Anti-neutrophilic cytoplasmic antibodies (ANCA) positivity: either a typical cytoplasmic-ANCA pattern by immunofluorescence test (IIF), and/or positivity in the proteinase-3 enzyme-linked immunosorbent assay (Pr3 ELISA), or positivity in the myeloperoxidase (MPO) ELISA, with or without perinuclear-ANCA (ANCA result will be confirmed by a nominated reference laboratory)
- •3. Biopsy-proven necrotising and/or crescentic glomerulonephritis, in the absence of another defined glomerulopathy, with severe renal impairment as defined by either:
- •3.1. Oliguria (less than 400 ml/24 hr) or
- •3.2. Intention to commence dialysis within 48 hours of admission
排除标准
- •1. Aged less than 18 or over 80
- •2. Inadequate contraception in women of child-bearing age
- •3. Pregnancy
- •4. Usually exclude patients with previous malignancy (unless agreed with trial coordinators)
- •5. Hepatitis B antigenaemia or detectable anti-hepatitis C virus antibody
- •6. Known anti-human immunodeficiency virus (anti-HIV) (HIV testing is not a requirement for this trial)
- •7. Diagnosis of Churg-Strauss syndrome, Henoch-Schonlein purpura, rheumatoid vasculitis, mixed essential cryoglobulinaemia, systemic lupus erythematosus, or the presence of circulating anti-glomerular basement membrane (anti-GBM) antibodies and linear gamma G immunoglobulin (IgG) staining of the GBM on renal biopsy, with intent to treat as anti-GBM mediated nephritis
- •8. Life-threatening non-renal manifestations of vasculitis, including alveolar haemorrhage requiring mechanical ventilation within 24 hours of admission
- •9. On dialysis for more than two weeks prior to referral
- •10. Significant baseline renal impairment: creatinine greater than 200 mmol/l one year or more before presentation
- •11. A second clearly defined cause of renal failure (e.g. urinary tract obstruction; not acute tubular necrosis [ATN])
- •12. Previous episode of biopsy-proven necrotising and/or crescentic glomerulonephritis
- •13. Intravenous methylprednisolone (IVMeP), plasma exchange (PE) or pulsed intravenous cyclophosphamide within the preceding year
- •14. More than two weeks treatment with oral cyclophosphamide (Cyc) or azathioprine (Aza)
- •15. More than three months treatment with oral corticosteroids (OCS)
- •16. Allergy to study medications (excluding prophylactic agents)
- •17. Previous IVMeP therapy, which exceeds a single dose of 500 mg prior to referral to the participating centre
研究者
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