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

Inclusion Criteria:

- Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months
prior to Screening

- Male or female subject between 10 and 16 years of age, inclusive at the time of
Screening

- Subject is currently being 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 greater than or equal to 8.4 and less than or equal to
10.2 mg/dL

- A phosphorus value less than or equal to 6.5 mg/dL

- An intact parathyroid hormone value greater than 300 pg/mL and less than or
equal to 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