Pediatric Chronic Kidney Disease Safety and Efficacy
Chronic Kidney Disease, Hyperparathyroidism, Hyperparathyroidism, Secondary
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring dialysis, sensipar, mimpara, hemodialysis, peritoneal dialysis, renal, parathyroid hormone, pediatric
Eligibility Criteria
Inclusion Criteria:
- Age 6 to less than 18 years at screening
- Diagnosed with CKD and SHPT receiving hemodialysis or peritoneal dialysis for ≥ 2 months before randomization
- Dry weight ≥ 12.5 kg at screening
- iPTH obtained from the central laboratory must be > 300 pg/mL (31.8 pmol/L)
- Serum calcium (corrected) obtained from the central laboratory must be ≥ 8.8 mg/dL (2.2 mmol/L)
- Serum phosphorus obtained from the central laboratory ≥ 4.0 mg/dL (1.3 mmol/L) for children 6 to less than 12 years old, or ≥ 3.5 mg/dL (1.1 mmol/L) for children 12 to less than 18 years old
- Subjects already receiving vitamin D sterols (either calcitriol or a synthetic analog), a stable dose within the last 2 months prior to randomization
- Subjects taking growth hormone, a stable dose defined as no change > than 20% in the last 2 months prior to randomization
- Subjects on anti-convulsant medication must be on a stable dose for 3 months, and have a therapeutic blood level of the anti-convulsant at the time of randomization
- Subjects must be on a dialysate calcium concentration of ≥ 2.5 mEq/L (1.25 mmol/L) for at least 2 months prior to randomization
Exclusion Criteria:
- Underwent parathyroidectomy in the last 6 months
- Anticipated parathyroidectomy within 6 months after randomization
- Received therapy with cinacalcet (sensipar/mimpara) within the last month
- A new onset of seizure or worsening of a pre-existing seizure disorder within the last 3 months
- Scheduled date for kidney transplant from a known living donor that makes completion of the study unlikely
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Cinacalcet
Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks.