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Table 1 Eligibility criteria

From: 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

Inclusion criteria
 1. Signed informed consent
 2. Patients on maintenance hemodialysis for 90 days or longer
 3. Men or women aged ≥20 and ≤80 years old
 4. No treatment with VDRAs for more than 4 weeks prior to this study
 5. Serum calcium level ≤10.0 mg/dL
 6. Serum phosphate level ≤6.0 mg/dL
 7. Serum intact PTH level ≤180 pg/mL
Exclusion criteria
 1. History within 12 weeks of myocardial infarction, stroke, aortic dissection/rupture, amputation of a lower limb, coronary revascularization or bypass surgery, lower limb revascularization or bypass surgery
 2. Heart failure of NYHA grade III or IV
 3. Respiratory failure with PaO2 <60 mmHg or SpO2 <90 %
 4. Life expectancy shorter than 1 year due to known malignant, infectious, or other diseases
 5. Abnormal liver function tests exceeding ×3 upper normal limits
 6. Pregnant or lactating females or females planning to be pregnant
 7. History of an allergic reaction to alfacalcidol
 8. Participation to other interventional studies within 12 weeks prior to this study
 9. Inappropriate for this study as judged by an attending investigator
  1. VDRAs vitamin D receptor activators, PTH parathyroid hormone, NYHA New York Heart Association, PaO 2 arterial oxygen pressure, SpO 2 oxygen saturation measured by pulse oxymeter