Abstract
Activation 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. The 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. Between July 2008 and January 2011, a total of 976 participants were randomized. The final results are expected in the second half of 2016. The J-DAVID trial will provide valuable information whether or not administration of VDRA reduces the risk of CVD in hemodialysis patients. UMI01194
Highlights
Activation of vitamin D is severely impaired in patients with advanced stages of chronic kidney disease, those on hemodialysis
The excess risk may be attributable to impairment in traditional [4] and nontraditional risk factors associated with chronic kidney disease (CKD) [1] such as insulin resistance [5], inflammation [6], protein-energy wasting [7], and CKDmineral bone disorder (CKD-MBD) [8]
We designed an randomized controlled trial (RCT), the Japan Dialysis Active Vitamin D (J-DAVID) trial, to test a hypothesis that treatment with Vitamin D receptor activator (VDRA) reduces the risk of cardiovascular disease (CVD) events in hemodialysis patients
Summary
Study design The J-DAVID trial is an RCT with a prospective randomized open-label blinded endpoint (PROBE) design. Population The target population of this study was maintenance hemodialysis patients whose serum calcium was ≤10.0 mg/ dL, phosphate was ≤6.0 mg/dL, and intact PTH was ≤180 pg/mL without taking any VDRA at screening. These values derived from the 2006 version of the clinical practice guideline by the Japanese Society for Dialysis Therapy (JSDT) [36]. Screening and enrollment Eligible patients were screened at 207 study sites in 27 out of 47 prefectures in Japan (Fig. 2). The registration forms were sent by FAX to the Data Center at Osaka City University for registration and randomization.
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