A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
Condition: End-Stage Renal Disease; Secondary Hyperparathyroidism
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: paricalcitol
Intervention description: Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 10 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects

Summary:

      The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages
      10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal
      dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will
      be in the dosing period of the study for 12 weeks in order to evaluate the incidence of
      hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and
      all 12 will receive paricalcitol capsules.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months
             prior to Screening

          -  Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism

          -  For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor
             [VDR] Activators or those who have completed a 2 to 12 week washout), the subject must
             meet the following laboratory criteria prior to enrollment:

               -  A corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dL

               -  A phosphorus value ≤ 6.5 mg/dL

               -  An intact parathyroid hormone (iPTH) value > 300 pg/mL and less ≤ 2000 pg/mL

        Exclusion Criteria:

          -  Subject is expected or scheduled to receive a living donor kidney transplant within 3
             months of Screening or is a kidney transplant patient requiring full immunosuppressant
             therapy

          -  Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of
             Screening (per investigator discretion)

          -  Subject has had a parathyroidectomy within 12 weeks prior to Screening

          -  Subject has had symptomatic or significant hypocalcemia requiring VDR Activator
             therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to
             Screening

          -  Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an
             equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect
             calcium or bone metabolism within 4 to 8 weeks prior to Dosing

          -  Subject is receiving cinacalcet at the time of Screening