Pediatric Chronic Kidney Disease Safety and Efficacy

Secondary hyperparathyroidism (SHPT) is a condition that can develop early in patients with
chronic kidney disease (CKD), usually gets worse over time, and is known to cause problems
for patients on dialysis. Children on dialysis can have a wide range of bone and growth
issues, and common treatments have a chance of making these things worse by increasing serum
calcium and serum phosphorus. Cinacalcet has been shown to be effective in controlling
parathyroid hormone (PTH), calcium and phosphorus in adults. The purpose of this study is to
show that including cinacalcet in the treatment of SHPT will lower the levels of intact
parathyroid hormone (iPTH) in a larger number of pediatric patients with CKD who are
receiving dialysis, compared to a treatment regimen that does not include cinacalcet.

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