EUCTR2011-002586-38-SE进行中（未招募）不适用
A 12-week clinical double-blind, randomised study of cholecalciferol versus placebo in patients with chronic kidney disease stage 3-4 (CHICK). - Vitamin D in chronic kidney disease
Renapharma AB0 个研究点目标入组 100 人开始时间: 2011年8月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- 性别
- All
入选标准
- •Males or females aged 18-85
- •A calculated GFR of 59 to 15 mL/min/1.73 m2 body surface according to the Modification of Diet in Renal Disease (MDRD) formula
- •Intact PTH above 6.8 pmol/L (70 pg/mL)
- •Calcidiol levels below 75 nmol/L (30 ng/mL)
- •Have signed informed consent to participate in the study
- •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 30
排除标准
- •Assumed need for dialysis or renal transplantation within six months
- •Ionized calcium above 1.30 mmol/L
- •Ongoing acute infectious or inflammatory disease. Ongoing chronic inflammatory disease other than chronic glomerulonephritis or systemic diseases with renal involvement
- •Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
- •Kidney transplant, known granulomatous disease, malabsorption, primary hyperparathyroidism, malignancy or other disease with effect on mineral metabolism
- •Ongoing treatment with parakalcitol, calcimimetics or a daily intake of pharmaceutical preparations containing >400 IE of vitamin D.
- •Planned vacation trip, during the study period, to a sunny country outside Sweden
- •Contraindication for Vitamin D3 Forte Renapharma®
研究者
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