NCT00135954已完成3 期
Treatment of Patients With Idiopathic Membranous Nephropathy at Risk for Renal Insufficiency: Comparison of Early Versus Late Start of Immunosuppressive Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- side effects
研究概览
简要总结
Patients with idiopathic membranous nephropathy at risk for renal failure can be identified in an early stage by measuring urinary low molecular weight proteins and urinary immunoglobulin G (IgG). This study evaluates the possible benefit of early start of immunosuppressive therapy in these high-risk patients.
详细描述
Inclusion Criteria:
- patients with idiopathic membranous nephropathy
- nephrotic syndrome
- normal renal function (serum creatinine [Screat] < 1.5 mg/dl)
- elevated urinary beta2-microglobulin and IgG
Immunosuppressive therapy consisting of:
- cyclophosphamide 1.5 mg/kg/day for 12 months
- prednisone orally, 0.5 mg/kg on alternate days for 6 months
- i.v. methylprednisolone 1000 mg on days 1,2,3, 60,61,62, 120,121,122
Study Groups:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic membranous nephropathy
- •Serum creatinine < 1.5 mg/dl
- •Nephrotic syndrome
排除标准
- •Infection
- •Instable angina
- •Systemic disease
- •Pregnancy
- •Renal vein thrombosis
- •Prior therapy with immunosuppressant agents
- •Liver dysfunction
- •Use of nonsteroidal anti-inflammatory drugs (NSAIDs)
研究组 & 干预措施
late intervention
Other
cyclophosphamide and steroids started at time of renal insufficiency
干预措施: Cyclophosphamide and steroids (Drug)
early intervention
Experimental
immediate start of cyclophosphamide and steroids
干预措施: Cyclophosphamide and steroids (Drug)
结局指标
主要结局
side effects
renal function (serum creatinine)
proteinuria
次要结局
未报告次要终点
研究者
研究点 (1)
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