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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
Sponsor: Sanofi
Summary
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®.
Official title: An Open-Label, Randomized, Parallel Group Study to Assess the Safety and Efficacy of Hectorol® (Doxercalciferol Capsules) in Pediatric Patients With Chronic Kidney Disease Stages 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Key Details
Gender
All
Age Range
5 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2017-01-19
Completion Date
2025-06-11
Last Updated
2026-07-02
Healthy Volunteers
No
Interventions
Doxercalciferol (GZ427397)
Pharmaceutical form: capsule Route of administration: oral
Calcitriol
Pharmaceutical form: capsule Route of administration: oral
Locations (23)
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