NCT01237028已完成不适用
Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 7
- 主要终点
- changes in proteinuria
研究概览
简要总结
This study will help to show the efficacy of vitamin D and address the optimal strategy to minimize renal injury in 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven Ig AN patients aged 20-70 years
- •Patients with residual proteinuria > 500 mg/g creatinine despite renin-angiotensin system blockade and adequate blood pressure control for more than 3 months
- •Patients who give informed consent, and 4) estimated GFR >= 30 ml/min/1.73 m2.
排除标准
- •patients < 20 years or > 70 years
- •hypersensitivity to vitamin D analogs
- •patients who need urgent dialysis
- •hypercalcemia within 3 months (uncorrected serum calcium level > 10.2 mg/dL)
- •clinical features of rapidly progressive glomerulonephritis
- •life expectancy less than 24 months
- •uncontrolled hypertension
- •decompensated liver or lung disease
- •symptomatic heart failure (NYHA class II-IV or LVEF < 40%)
- •estimated GFR < 30 ml/min/1.73 m2.
研究组 & 干预措施
oral calcitriol
Experimental
Calcio®
干预措施: Calcitriol (Drug)
结局指标
主要结局
changes in proteinuria
时间窗: random urine protein/creatinine ratio every 2month and 24hour urine protein every 6month
comparison of proteinuria amount checked by random urine protein/creatinine and 24hour urine protein
次要结局
- changes in serum creatinine(serum creatinine every 2month)
- changes in systolic blood pressure and diastolic pressure(check blood pressure at very first visit and every 2-month)
- changes in serum 25(OH)2D3, 1,25(OH)2D3, parathyroid hormone(every 6month)
- changes in serum inflammatory markers (hsCRP, IL-6)(every 6month)
- changes in urinary biomarkers (angiotensinogen, angiotensin II, TGF-beat, IL-6, MCP-1, TNF-alpha)(every 6month)
研究者
研究点 (7)
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