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

Sanofi

Status and phase: Active, not recruiting; Phase 3

Conditions: Secondary Hyperparathyroidism-Chronic Kidney Disease

Treatments: Drug: Doxercalciferol (GZ427397); Drug: Calcitriol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02859896

U1111-1178-4657 (Other Identifier)

LPS14314

Details and patient eligibility

About

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®.

Full description

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

Enrollment: 84 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Hectorol

Experimental group

Description:

Hectorol (Doxercalciferol) will be administered orally two to three times weekly dependent on patient age. A dose titration scheme is used to individualize the dose to the patient's iPTH management.

Treatment:

Drug: Doxercalciferol (GZ427397)

Rocaltrol

Active Comparator group

Description:

Rocaltrol (Calcitriol) will be administered orally seven days/week. A dose titration scheme is used to individualize the dose to the patient's iPTH management.

Treatment:

Drug: Calcitriol