Effect of oral alfacalcidol on clinical outcomes in patients without secondary hyperparathyroidism receiving maintenance hemodialysis

The J-DAVID clinical trial was conducted to determine if treatment with active vitamin D sterols would reduce the risk of all-cause mortality in people with chronic kidney disease (CKD). This patient population has elevated cardiovascular risk, possibly as a byproduct of impaired vitamin D activation by the kidneys.

The J-DAVID clinical trial was conducted to determine if treatment with active vitamin D sterols would reduce the risk of all-cause mortality in people with chronic kidney disease (CKD). This patient population has elevated cardiovascular risk, possibly as a byproduct of impaired vitamin D activation by the kidneys. The researchers recruited patients undergoing maintenance hemodialysis at centers across Japan to participate in their randomized trial of oral alfacalcidol. Participants were excluded if they presented with secondary hyperparathyroidism, with 495 individuals ultimately receiving daily treatment with the vitamin D receptor activator and 481 serving as controls. The primary endpoint was a composite measure of fatal and nonfatal cardiovascular events—including but not limited to myocardial infarction, congestive heart failure, and stroke—during 48 months of followup. A total of 21.1% of the alfacalcidol patients experienced the primary outcome, compared with 17.9% of the controls. That difference was not considered to be statistically significant—nor was the between-group difference in all-cause mortality, the study's secondary endpoint. Serious adverse events described as cardiovascular, infectious, or malignancy-related in nature also were comparable across the two groups. The researchers concluded that the evidence does not support use of active vitamin D in this setting.