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

NCT02859896

TerminatedPhase 3

Sponsor: Sanofi

Conditions: Secondary Hyperparathyroidism-Chronic Kidney Disease

Interventions: Doxercalciferol (GZ427397), Calcitriol

Countries: United States, Chile

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®.

Eligibility overview

Sex: ALL

Age: 5 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 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.

Locations (23)

Birmingham, Alabama, United States
Los Angeles, California, United States
Sacramento, California, United States
New Haven, Connecticut, United States
Miami, Florida, United States
Miami, Florida, United States
Chicago, Illinois, United States
Minneapolis, Minnesota, United States
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
New Hyde Park, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Pittsburgh, Pennsylvania, United States
Greenville, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Marshfield, Wisconsin, United States
Concepción, Biobio, Chile
Santiago, Reg Metropolitana de Santiago, Chile