EUCTR2016-002913-23-ES进行中（未招募）1 期
Phase II clinical trial to evaluate the effect of 25 OH vitamin D on renal progression in patients with Chronic Kidney Disease stage 3 and 25OH vitamin D deficiency - VITARENA
Fundación Hospital Alcorcón0 个研究点目标入组 170 人开始时间: 2016年8月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 170
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Age 18-80 years
- •Stage 3 Kidney Disease ( CKD EPI eGFR 60-30 ml / min / 1.73m2 )
- •25 OH vitamin D levels < 15 ng / Ml
- •microalbuminuria / creatinine ratio > 30 mg / g confirmed in first morning urine
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Bone fracture in the last three months
- •Previous condition of intestinal malabsorption or chronic diarrhea.
- •Treatment with phenobarbital, phenytoin , rifampin , sucralfate , digoxin , steroids or other medication may affect the metabolism of vitamin D
- •Previous liver failure
- •Primary hyperparathyroidism
- •calcimimetic treatment in the last 6 months
- •active granulomatous disease
- •Current treatment with some form of vitamin D
- •Pregnancy- lactation
- •Background of calcium nephrolithiasis well documented origin
- •serum phosphate > 5.5 mg / dL in any determination in the last 3 months
- •Serum calcium > 10.0 mg / dL in any determination in the last 3 months
研究者
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