Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
NCT ID: NCT02859896
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
21 participants
INTERVENTIONAL
2017-01-19
2025-06-11
Brief Summary
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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®.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hectorol
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.
Doxercalciferol (GZ427397)
Pharmaceutical form: capsule
Route of administration: oral
Rocaltrol
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.
Calcitriol
Pharmaceutical form: capsule
Route of administration: oral
Interventions
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Doxercalciferol (GZ427397)
Pharmaceutical form: capsule
Route of administration: oral
Calcitriol
Pharmaceutical form: capsule
Route of administration: oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
5 Years
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Children's Hospital Of Alabama Site Number : 8400022
Birmingham, Alabama, United States
Cedars Sinai Medical Center Site Number : 8400033
Los Angeles, California, United States
UC DAVIS Medical Center Site Number : 8400005
Sacramento, California, United States
Yale University School of Medicine Site Number : 8400029
New Haven, Connecticut, United States
University of Miami Site Number : 8400006
Miami, Florida, United States
Nicklaus Children's Hospital Site Number : 8400008
Miami, Florida, United States
Rush University Medical Center Site Number : 8400020
Chicago, Illinois, United States
University of Minnesota Site Number : 8400014
Minneapolis, Minnesota, United States
Hackensack University Site Number : 8400010
Hackensack, New Jersey, United States
Goryeb Children's Hospital Site Number : 8400016
Morristown, New Jersey, United States
Cohen Children's Medical Center of NY Site Number : 8400017
New Hyde Park, New York, United States
Mount Sinai Medical Center Site Number : 8400007
New York, New York, United States
Duke University Medical Center Site Number : 8400034
Durham, North Carolina, United States
East Carolina University, Brody School of Medicine Site Number : 8400025
Greenville, North Carolina, United States
Children's Hospital of Pittsburgh Site Number : 8400028
Pittsburgh, Pennsylvania, United States
Greenville Hospital System 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 Site Number : 8400026
Salt Lake City, Utah, United States
Virginia Commonwealth University Site Number : 8400009
Richmond, Virginia, United States
Marshfield Clinic Site Number : 8400001
Marshfield, Wisconsin, United States
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520004
Concepción, Región del Biobío, Chile
Countries
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Other Identifiers
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U1111-1178-4657
Identifier Type: REGISTRY
Identifier Source: secondary_id
LPS14314
Identifier Type: -
Identifier Source: org_study_id
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