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BackgroundActivation of vitamin D is severely impaired in patients with advanced stages of chronic kidney disease, particularly those on hemodialysis. Observational studies have shown that the use of vitamin D receptor activators (VDRAs) is associated with lower risk of death from all-cause and cardiovascular disease (CVD) in dialysis populations regardless of serum parathyroid hormone (PTH) level. So far, however, there is no prospective trial to evaluate the effect of VDRAs administration on CVD prevention in hemodialysis patients.MethodsThe Japan Dialysis Active Vitamin D (J-DAVID) trial is a multi-center study with a prospective randomized open-label blinded endpoint (PROBE) design. The subjects are maintenance hemodialysis patients whose serum calcium is ≤10.0 mg/dL, phosphate is ≤6.0 mg/dL, and intact PTH is ≤180 pg/mL without taking any VDRA. The subjects (target number is 972) are randomized to one of the two treatment arms: treatment with oral alfacalcidol or treatment without using any VDRA and followed up for 48 months. The primary outcome is the composite of fatal and nonfatal cardiovascular events (myocardial infarction, heart failure requiring hospitalization, stroke, aortic dissection/rupture, amputation of lower limb due to ischemia, and cardiac sudden death, coronary revascularization, and leg artery revascularization). The secondary outcome is all-cause death. The primary analysis will be the intention-to-treat analysis of the primary endpoint.ResultsBetween July 2008 and January 2011, a total of 976 participants were randomized. The final results are expected in the second half of 2016.ConclusionsThe J-DAVID trial will provide valuable information whether or not administration of VDRA reduces the risk of CVD in hemodialysis patients.Trial registrationUMIN1194

renal replacement therapy

Vitamin D receptor activator and prevention of cardiovascular events in hemodialysis patients—rationale and design of the Japan Dialysis Active Vitamin D (J-DAVID) trial