Clareo Health | Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
The total study duration per participant was approximately up to 28 weeks.
Age
5–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
The participant had a serum 25-hydroxyvitamin D level \<30 ng/mL at screening.
The participant had a corrected calcium ≥10 mg/dL at the Week -2 visit.
The participant had 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 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.
