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

• Status: Recruiting
• Trial end date: 2025-11-12
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

Evaluate the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH).

Secondary Objectives:

• Evaluate the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules.

• Determine the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: 1 alpha-hydroxyergocalciferol; Calcitriol; Ergocalciferols

Criteria

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.