Clareo Health | 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
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
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Lead
AbbVie (prior sponsor, Abbott)
Age
10–16
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
