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Terminated Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02859896

Public ClinicalTrials.gov record NCT02859896. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 10:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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®.

Study identification

NCT ID
NCT02859896
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
21 participants

Conditions and interventions

Eligibility (public fields only)

Age range
5 Years to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 18, 2017
Primary completion
Jun 10, 2025
Completion
Jun 10, 2025
Last update posted
Jul 1, 2026

2017 – 2025

United States locations

U.S. sites
21
U.S. states
16
U.S. cities
20
Facility City State ZIP Site status
Children's of Alabama- Site Number : 8400022 Birmingham Alabama 35233
Cedars-Sinai Medical Center- Site Number : 8400033 Los Angeles California 90048
University of California Davis Health- Site Number : 8400005 Sacramento California 95817
Yale University School of Medicine- Site Number : 8400029 New Haven Connecticut 06510
University of Miami Hospital- Site Number : 8400006 Miami Florida 33136
Nicklaus Children's Hospital - Miami - Southwest 62nd Avenue- Site Number : 8400008 Miami Florida 33155
Rush University Medical Center- Site Number : 8400020 Chicago Illinois 60612
M Health Fairview University of Minnesota Medical Center - West Bank- Site Number : 8400014 Minneapolis Minnesota 55454
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400010 Hackensack New Jersey 07601
Goryeb Chidlren's Hospital- Site Number : 8400016 Morristown New Jersey 07962
Cohen Children's Medical Center- Site Number : 8400017 New Hyde Park New York 11040
The Mount Sinai Hospital- Site Number : 8400007 New York New York 10029
Duke University Medical Center- Site Number : 8400034 Durham North Carolina 27710
East Carolina University- Site Number : 8400025 Greenville North Carolina 27858
UPMC Children's Hospital of Pittsburgh- Site Number : 8400028 Pittsburgh Pennsylvania 15224
Greenville Memorial Hospital- Site Number : 8400027 Greenville South Carolina 29605
Vanderbilt University Medical Center- Site Number : 8400024 Nashville Tennessee 37292
Texas Children's Hospital- Site Number : 8400013 Houston Texas 77030
University of Utah Health Hospital- Site Number : 8400026 Salt Lake City Utah 84132
Virginia Commonwealth University Medical Center- Site Number : 8400009 Richmond Virginia 23219
Marshfield Medical Center - Marshfield- Site Number : 8400001 Marshfield Wisconsin 54449

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02859896, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 1, 2026 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02859896 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →