Table 1 Main inclusion and exclusion criteria

Main inclusion criteria

 Age ≥ 18 years

 Maintenance hemodialysis 3×/week for ≥ 3 months and ≤ 3 years

 sHPT defined by:

  • PTH ≥ 300 pg/mL and no prior calcimimetic drug, or

  • PTH ≥ 300 pg/mL after washout of vitamin D for 4 weeks

  • Patients after washout of cinacalcet for 4 weeks

 Serum calcium ≥ 2.08 mmol/L

 LVH ± cardiac fibrosis on echocardiography

 Optimal fluid composition (BCM measurement); pulmonary edema excluded (lung ultrasound)

 No substantial dose change of calcium supplements, phosphate binders, dialysate calcium, or active vitamin D for 4 weeks before screening

Main exclusion criteria

 Unstable medical condition

 Significantly impaired LV systolic function or hemodynamically effective heart valve defects

 Anticipated parathyroidectomy

 Scheduled kidney transplant from a living donor

 Uncontrolled hyperphosphatemia

 Active participation in another clinical trial

 Sensitivity or intolerance to administered products

 Women who are pregnant or breast feeding

 Disorder compromising the ability to give informed consent and/or to comply with the study procedures

 Contraindications for MRI