Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

The total study duration per patient will be approximately up to 28 weeks.

Inclusion criteria :

- Male or female aged 5 to 18 years old.

- Weight ≥15 kg.

- Chronic kidney disease (CKD) Stage 3 or 4 not on dialysis, defined as glomerular
filtration rate (GFR) between 15 and 59 mL/min/1.73m^2 (established by Schwartz
equation) at Week -2 visit.

- Intact parathyroid hormone (iPTH) value >100 pg/mL for CKD Stage 3 or >160 pg/mL for
CKD Stage 4, at Week -2 visit.

- Signed informed consent/assent form.

Exclusion criteria:

- The patient has a serum 25-hydroxyvitamin D level <30 ng/mL at screening.

- The patient has a corrected calcium ≥10 mg/dL at the Week -2 visit.

- The patient has a serum phosphorus >4.5 mg/dL for children 13 to 18 years of age; >5.8
mg/dL for children 5 to 12 years of age at the Week -2 visit.

- The patient is anticipated to require maintenance hemodialysis within 3 months.

- The patient used cinacalcet or vitamin D sterol therapies such as calcitriol,
doxercalciferol, or paricalcitol within 14 days prior to the baseline visit.

- The patient has a history of, or active, symptomatic heart disease within 12 months
prior to the baseline (Week 0) visit.

- The patient currently has a chronic gastrointestinal disease (ie, malabsorption,
severe chronic diarrhea, chronic ulcerative colitis, or ileostomy).

- The patient currently has primary hyperparathyroidism or has had a total
parathyroidectomy.

- The patient has an active malignancy.

- The patient is unable to swallow a capsule in size similar to the Hectorol® and
Rocaltrol® capsules.

- The patient has a history of sensitivity or allergy to doxercalciferol, calcitriol or
other vitamin D analogs.

- The patient currently uses aluminum or magnesium-based binders.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.