NCT01442272Unknown4 期
Clinical Trial, Open, Parallel Groups , Value the Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Protein/creatinine quotient and albumin/creatinine in matinal urine sample: basal and 3 period months after a month of the therapeutic protocol beginning.
研究概览
简要总结
The purpose of this study is to determine the value the additional antiproteinuric effects of vitamin D derivatives treatment, in patients with Chronic Kidney Illness phase II-IV, with lack of vitamin D and residual proteinuria higher 0,5 grams/day.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female Patients older 18 years old
- •Patients have signed written informed consent
- •Chronic Kidney Illness phase II-IV plus residual proteinuria >0,5 grams/day (two or more consecutive occasions) and plus beta blockers treatment from AARS during al least 3 months.
- •Serum levels of calcifediol in the lack of level (15-30 ng/ml).
排除标准
- •Bad control of high blood pressure (higher or same 180/110 mmHg)
- •Bad control of diabetes (HbA1c higher 9,5 in the last three months period)
- •Hypercalcemia (<10,2 mg/dL) o hyperphosphatemia(>5,5 mg/dL), CaxPO4>50, hypercalciuria (urin Ca/Cr quotient > 0,15)
- •Vitamin D treatment or any analogous
- •Hepatic failure ( AST o ALT > 3 times higher than normal limit)
- •medical history of poor nutrient intestinal absorptions or chronic diarrhea
- •Active nephrolithiasis
- •Treatment with medication wich can change vitamin D metabolism (phenobarbital, phenytoin, rifampicin)
- •Participation in other Clinic Trial in 3 last months
- •Active Alcoholism
- •Neoplasia precedent (except cutaneous no melanoma)
- •Pregnant women or while breastfeeding
- •Vitamin D hypersensitivity or any its excipient hypersensitivity
- •Any other condition from Research
研究组 & 干预措施
Habitual medication withuot additional
No Intervention
干预措施: Habitual medication (Drug)
Habitual medication plus Hidroferol®
Active Comparator
干预措施: Hidroferol® (Drug)
结局指标
主要结局
Protein/creatinine quotient and albumin/creatinine in matinal urine sample: basal and 3 period months after a month of the therapeutic protocol beginning.
时间窗: 1-3 month
次要结局
未报告次要终点
研究者
研究点 (2)
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