Prospective, randomized, open-label, blinded-endpoint trial to examine the effect of active vitamin D on cardiovascular events in hemodialysis patients: Japan Dialysis Active Vitamin D trial (J-DAVID) - Japan Dialysis Active Vitamin D trial (J-DAVID)

J-DAVID Research Group0 个研究点目标入组 972 人开始时间: 2008年6月19日最近更新: 2023年10月17日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 972

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Participant recruitment was started in June 2008, and the first one was registered and randomized in August 2008. We randomized 976 participants to the intervention group (alfacalcidol) or the control group (no VDRA) and followed up to 4 years. No significant difference was observed with the hazard ratio was 1.25 (95%CI, 0.94-1.67), P=0.127 for the primary composite cardiovascular endpoint.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 80years-old（—）
性别: All

入选标准

未提供

排除标准

•1) Myocardial infarction, stroke, aortic dissection/rupture, lower limb amputation in preceding 12 weeks, 2) Severe heart failure (NYHA class III or IV), 3) Respiratory failure (PaO2 < 60 mmHg or SpO2 < 90%), 4)Severe illness with life expectancy less than 1 year, 5) Liver dysfunction with AST or ALT elevation exceeding 3 x upper limit of normal, 6)Pregnant, lactating women or women who plan to be pregnant, 7) History of allergy to the test drug, 8) Participation to other intervention trails in the preceding 12 weeks, 9)Others who are judged inappropriate for the study by the physician

研究者

发起方

J-DAVID Research Group

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