- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02859896
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
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
Primary Objective:
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®.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Biobío
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Concepción, Biobío, Chile
- Investigational Site Number :1520004
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Reg Metropolitana De Santiago
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Santiago, Reg Metropolitana De Santiago, Chile
- Investigational Site Number :1520003
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Alabama
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Birmingham, Alabama, United States, 35233
- Investigational Site Number :8400022
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California
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Los Angeles, California, United States, 90027
- Investigational Site Number :8400023
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Los Angeles, California, United States, 90048
- Investigational Site Number :8400033
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Sacramento, California, United States, 95817
- Investigational Site Number :8400005
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Connecticut
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New Haven, Connecticut, United States, 06520-8017
- Investigational Site Number :8400029
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Florida
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Miami, Florida, United States, 33101
- Investigational Site Number :8400006
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Miami, Florida, United States, 33155
- Investigational Site Number :8400008
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Illinois
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Chicago, Illinois, United States, 60612
- Investigational Site Number :8400020
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Indiana
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Indianapolis, Indiana, United States, 46202
- Investigational Site Number :8400036
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Minnesota
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Minneapolis, Minnesota, United States, 55454
- Investigational Site Number :8400014
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Mississippi
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Jackson, Mississippi, United States, 39216
- Investigational Site Number :8400015
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Investigational Site Number :8400010
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Morristown, New Jersey, United States, 07962
- Investigational Site Number :8400016
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New York
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New Hyde Park, New York, United States, 11040
- Investigational Site Number :8400017
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New York, New York, United States, 10021
- Investigational Site Number :8400007
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Syracuse, New York, United States, 13210
- Investigational Site Number :8400021
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North Carolina
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Durham, North Carolina, United States, 27710
- Investigational Site Number :8400034
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Greenville, North Carolina, United States, 27834
- Investigational Site Number :8400025
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Oregon
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Portland, Oregon, United States, 97227
- Investigational Site Number :8400004
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Portland, Oregon, United States, 97239-3098
- Investigational Site Number :8400035
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Investigational Site Number :8400028
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South Carolina
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Greenville, South Carolina, United States, 29605
- Investigational Site Number :8400027
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Tennessee
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Nashville, Tennessee, United States, 37292
- Investigational Site Number :8400024
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Texas
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Houston, Texas, United States, 77030
- Investigational Site Number :8400013
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Houston, Texas, United States, 77030
- Investigational Site Number :8400019
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Utah
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Salt Lake City, Utah, United States, 84113
- Investigational Site Number :8400026
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Virginia
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Richmond, Virginia, United States, 23298
- Investigational Site Number :8400009
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Investigational Site Number :8400001
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 patient has a serum 25-hydroxyvitamin D level <30 ng/mL at screening.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Pharmaceutical form: capsule Route of administration: oral
Other Names:
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Active Comparator: 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.
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Pharmaceutical form: capsule Route of administration: oral
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Percentage of participants achieving two consecutive ≥30% reductions in iPTH
Time Frame: Baseline up to Week 12
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Baseline up to Week 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Percentage change from baseline in iPTH
Time Frame: Baseline, Week 12, Week 24
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Baseline, Week 12, Week 24
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Number of hypercalcemia events (albumin corrected serum calcium >10.2 mg/dL)
Time Frame: Up to Weeks 12 and 24
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Up to Weeks 12 and 24
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Number of participants with adverse events
Time Frame: Baseline up to Week 24
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Baseline up to Week 24
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Assessment of pharmacokinetic (PK) parameter: Serum 1,25-dihydroxyvitamin D2 concentration-time data
Time Frame: At Week -2, Baseline, and then within 24 hours of the most recent dose of Hectorol® at Weeks 2, 4, 6, 8 or 10 (whichever week is not used for serial PK assessment), and 12
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At Week -2, Baseline, and then within 24 hours of the most recent dose of Hectorol® at Weeks 2, 4, 6, 8 or 10 (whichever week is not used for serial PK assessment), and 12
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urologic Diseases
- Endocrine System Diseases
- Renal Insufficiency
- Parathyroid Diseases
- Neoplastic Processes
- Kidney Diseases
- Renal Insufficiency, Chronic
- Hyperparathyroidism
- Neoplasm Metastasis
- Hyperparathyroidism, Secondary
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Micronutrients
- Membrane Transport Modulators
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vasoconstrictor Agents
- Calcium Channel Agonists
- Calcitriol
- 1 alpha-hydroxyergocalciferol
Other Study ID Numbers
- LPS14314
- U1111-1178-4657 (Other Identifier: UTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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