Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Renal recovery
研究概览
简要总结
The purpose of this study is to test whether additional therapy with plasma exchange improves the chances of kidney recovery in severe kidney vasculitis.
详细描述
Primary systemic vasculitis associated with autoantibodies to neutrophil cytoplasmic antigens (ANCA), is the most frequent cause of rapidly progressive glomerulonephritis. Renal failure at presentation often progresses to end stage renal disease despite immunosuppressive therapy. We investigated whether the addition of plasma exchange was more effective than intravenous (IV) methyl prednisolone in the achievement of renal recovery for ANCA associated systemic vasculitis presenting with a serum creatinine above 500umol/l (5.8mg/dl).
137 patients with a new diagnosis of ANCA associated systemic vasculitis, serum creatinine above 500umol/l (5.8mg/dl) and a renal biopsy demonstrating a focal, necrotizing glomerulonephritis were randomized to receive seven plasma exchanges or IV methyl prednisolone 1000mg/day for three days. Both groups were treated with cyclophosphamide and oral prednisolone. The primary end-point was dialysis independence with a serum creatinine below 500umol/l (5.8mg/dl) at three months. Secondary end-points included renal and patient survival at 12 months and severe adverse event rates.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Wegener's granulomatosis or microscopic polyangiitis, using criteria adapted by EUVAS from the disease definitions of the Chapel Hill consensus conference
- •Biopsy proven, pauci-immune, necrotising and/or crescentic glomerulonephritis, in the absence of other defined glomerulopathy
- •Severe renal impairment defined by: (i) oliguria (<400ml/24hr), or (ii) intention to commence dialysis within 48 hours of admission, and (iii) creatinine >500umol/l (5.8mg/dl).
排除标准
- •Age under 18 or over 80 years
- •Inadequate contraception in women of child-bearing age
- •Pregnancy
- •Previous malignancy
- •Hepatitis B antigenaemia, anti-hepatitis C virus or anti-human immunodeficiency virus antibody
- •Diagnosis of Churg-Strauss syndrome, Henoch-Schönlein purpura, rheumatoid vasculitis, mixed essential cryoglobulinaemia or systemic lupus erythematosus
- •Circulating anti-GBM antibodies or linear IgG staining of the GBM on renal biopsy
- •Life-threatening non-renal manifestations of vasculitis, including alveolar hemorrhage requiring mechanical ventilation within 24 hours of admission
- •On dialysis for > two weeks prior to entry
- •Creatinine > 200umol/l (2.3mg/dl) one year or more before entry
- •A second clearly defined cause of renal failure
- •Previous episode of biopsy-proven necrotising and/or crescentic glomerulonephritis
- •> two weeks treatment with cyclophosphamide or azathioprine
- •> 500mg IV methyl prednisolone
- •Plasma exchange within the preceding year
- •> three months treatment with oral prednisolone
- •Allergy to study medications.
研究组 & 干预措施
1
Plasma exchange x 7 over 14 days
干预措施: Plasma exchange (Procedure)
2
Methyl prednisolone 1g x 3
干预措施: Intravenous methyl prednisolone (Drug)
2
Methyl prednisolone 1g x 3
干预措施: Methyl prednisolone (Drug)
结局指标
主要结局
Renal recovery
时间窗: Three months
次要结局
- Severe adverse events(12 months)
- End stage renal disease at 12 months(12 months)
- Serum creatinine at 12 months(12 months)