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Table 1 Eligibility criteria

From: Rationale and study design of a randomized controlled trial for development of a treatment strategy for chronic kidney disease–mineral and bone disorder by multilateral mechanism of etelcalcetide hydrochloride (the DUET study)

Inclusion criteria
  1. Patients undergoing maintenance hemodialysis three times per week
  2. Patients with dialysis vintage ≥ 1 year
  3. Patients with stable disease judged from medical records, physical examination, and laboratory tests
  4. Patients between 20 and 99 years of age
  5. iPTH levels ≥ 240 pg/mL for 4 months prior to the enrollment
  6. Corrected serum calcium level ≥ 8.4 mg/dL at enrollment
  7. Provision of written informed consent
Exclusion criteria
  1. A history of administration of etelcalcetide
  2. Administered bisphosphonates within 24 weeks of providing informed consent
  3. Primary hyperparathyroidism
  4. A history of parathyroidectomy or underwent interventional treatment of the parathyroid gland within 90 days of providing informed consent
  5. Scheduled to undergo parathyroidectomy or interventional treatment on the parathyroid gland
  6. Pregnant, breast feeding, or desire to bear children
  7. Severe complications including cancer causing hypercalcemia or severe infection at the time of providing informed consent
  8. Administered either, maxacalcitol over 10 μg three times weekly, calcitriol over 0.75 μg three times weekly, calcitriol over 0.75 μg three times weekly, another active VitD above half of the maximum dose, or precipitated calcium carbonate over 3 g/day
  9. Considered unsuitable to participate in this study as per the primary doctor’s judgment
  1. VitD vitamin D, iPTH intact parathyroid hormone