Pediatric Chronic Kidney Disease Safety and Efficacy
Condition: Chronic Kidney Disease; Hyperparathyroidism; Hyperparathyroidism, Secondary; Kidney Disease; Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: cinacalcet capsule; placebo; Standard of Care
Intervention description: Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.; Placebo tablets and capsules for sprinkling identical to active treatment.; All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.
Intervention MeSH terms: Cinacalcet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: dialysis; sensipar; mimpara; hemodialysis; peritoneal dialysis; renal; parathyroid hormone; pediatric

Summary:

      The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the
      current treatment of secondary hyperparathyroidism in children currently receiving dialysis
      compared to a treatment regimen that does not include cinacalcet.
    

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