Additive Renoprotective Effects of Oral Calcitriol in Nondiabetic Chronic Kidney Disease Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Changes in proteinuria
研究概览
简要总结
Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and lower glomerular filtration rate (GFR). And calcitriol was shown to have a preventive effect in progressive glomerular damage in a renal ablation model. Calcitriol, an active form of vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases.
Therefore, the objective of this study is to evaluate the anti-proteinuric effect of calcitriol in non-diabetic kidney disease patients. They will be treated with calcitriol and placebo for 24 weeks and observed for 24 weeks after treatment. Proteinuria, renal function, serum and urinary inflammatory markers, and adverse event will be monitored.
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, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nondiabetic kidney disease patients aged 19-70 years
- •MDRD GFR ≥ 30 mL/min/1.73m2
- •Patients with residual urine protein/creatinine ratio > 200 mg/g
- •Adequate blood pressure control as treated systolic blood pressure <=140 or diastolic <=90 mmHg with RAS inhibitor for more than 3 months
- •Normotensive patients untreated with RAS inhibitors
- •Serum intact PTH as 35-500 mg/dL and serum calcium less than 10.2 mg/dL
- •Patients who have not been treated vitamin D within the 3 months prior to signing the informed consent form
排除标准
- •Patients with nephrotic-range proteinuria (24 hour urine protein >3.5 g/24 hr)
- •Patients with rapidly progressive glomerulonephritis
- •Patients requiring renal replacement therapy immediately
- •Hypercalcemia (uncorrected serum calcium level > 10.2 mg/dL) within 3 months
- •Malignant hypertension
- •Heart failure (New York Heart Association [NYHA] functional class II to IV or LVEF less than 40%)
- •Severe chronic obstructive lung disease
- •Decompensated liver disease
- •Known allergy or hypersensitivity to vitamin D
- •Current treatment with steroids and/or immunosuppressive agents
- •No other active primary malignancy requiring treatment or that limits survival to ≤ 2 years
- •History of noncompliance to medical regimen
- •Inability to give an informed consent or to cooperate with researchers (e.g., psychiatric disorder)
研究组 & 干预措施
Calcitriol
干预措施: Calcitriol (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in proteinuria
时间窗: 6, 12 months after administration
Comparison of proteinuria amount checked by random urine protein/creatinine ratio
次要结局
- Changes in urinary renal damage markers(6, 12 months)
- Changes in renal function(3, 6, 9 and 12 months)
研究者
Yon Su Kim
Professor
Seoul National University Hospital