Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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
Funding Agency/Sponsor
Industry
Disease
Nephrology
Enrollment Eligibility
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.