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

Stopped early · Phase 3

Conditions studied: Secondary Hyperparathyroidism-Chronic Kidney Disease

In brief

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®.

Key facts

Study ID

NCT02859896

Run by

Sanofi

People needed

21

Starts

2017-01-19

Expected to finish

2025-06-11

Last updated by the study team

2026-07-02

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Children's of Alabama- Site Number : 8400022 — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center- Site Number : 8400033 — Los Angeles, California, United States
• University of California Davis Health- Site Number : 8400005 — Sacramento, California, United States
• Yale University School of Medicine- Site Number : 8400029 — New Haven, Connecticut, United States
• University of Miami Hospital- Site Number : 8400006 — Miami, Florida, United States
• Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400008 — Miami, Florida, United States
• Rush University Medical Center- Site Number : 8400020 — Chicago, Illinois, United States
• M Health Fairview University of Minnesota Medical Center - West Bank- Site Number : 8400014 — Minneapolis, Minnesota, United States
• Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400010 — Hackensack, New Jersey, United States
• Goryeb Chidlren's Hospital- Site Number : 8400016 — Morristown, New Jersey, United States
• Cohen Children's Medical Center- Site Number : 8400017 — New Hyde Park, New York, United States
• The Mount Sinai Hospital- Site Number : 8400007 — New York, New York, United States
• Duke University Medical Center- Site Number : 8400034 — Durham, North Carolina, United States
• East Carolina University- Site Number : 8400025 — Greenville, North Carolina, United States
• UPMC Children's Hospital of Pittsburgh- Site Number : 8400028 — Pittsburgh, Pennsylvania, United States
• Greenville Memorial Hospital- Site Number : 8400027 — Greenville, South Carolina, United States
• Vanderbilt University Medical Center- Site Number : 8400024 — Nashville, Tennessee, United States
• Texas Children's Hospital- Site Number : 8400013 — Houston, Texas, United States
• University of Utah Health Hospital- Site Number : 8400026 — Salt Lake City, Utah, United States
• Virginia Commonwealth University Medical Center- Site Number : 8400009 — Richmond, Virginia, United States
• Marshfield Medical Center - Marshfield- Site Number : 8400001 — Marshfield, Wisconsin, United States
• Investigational Site Number : 1520004 — Concepción, Biobio, Chile
• Investigational Site Number : 1520003 — Santiago, Reg Metropolitana de Santiago, Chile

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.