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 |
BCM body composition monitoring, LV left ventricular, LVH left ventricular hypertrophy, MRI magnetic resonance imaging, PTH parathyroid hormone, sHPT secondary hyperparathyroidism