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

Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: * Evaluated the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. * Determined the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.

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 participant had a serum 25-hydroxyvitamin D level \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 participant was anticipated to require maintenance hemodialysis within 3 months. * The participant used cinacalcet or vitamin D sterol therapies such as calcitriol, doxercalciferol, or paricalcitol within 14 days prior to the baseline visit. * The participant had a history of, or active, symptomatic heart disease within 12 months prior to the baseline (Week 0) visit. * The participant had a chronic gastrointestinal disease (ie, malabsorption, severe chronic diarrhea, chronic ulcerative colitis, or ileostomy). * The participant had primary hyperparathyroidism or has had a total parathyroidectomy. * The participant had an active malignancy. * The participant was unable to swallow a capsule in size similar to the Hectorol® and Rocaltrol® capsules. * The participant had a history of sensitivity or allergy to doxercalciferol, calcitriol or other vitamin D analogs. * The participant used aluminum or magnesium-based binders. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.