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)

UMIN ID: UMIN000001194

Registered date:19/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic kidney disease stage 5D
• Date of first enrollment: 2008/07/01
• Target sample size: 972
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

oral alfacalcidol
No treatment with active vitamin D or analog

Outcome(s)

• Primary Outcome: 1) Fatal or nonfatal cardiovascular events (acute myocardial infarction, congestive heart failure, stroke, aortic dissection/rupture, amputation of ischemic limb, cardiac sudden death) 2) Coronary intervention (POBA, stenting) or bypass grafting 3) Lower limb artery intervention (POBA, stenting) or bypass grafting
• Secondary Outcome: All-cause mortality

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 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

Related Information

• Primary Sponsor: J-DAVID Research Group
• Source(s) of Monetary Support: The Kidney Foundation, Japan