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

April 26, 2023 updated by: Sanofi

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

Detailed Description

The total study duration per patient will be approximately up to 28 weeks.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Biobío
      • Concepción, Biobío, Chile
        • Investigational Site Number :1520004
    • Reg Metropolitana De Santiago
      • Santiago, Reg Metropolitana De Santiago, Chile
        • Investigational Site Number :1520003
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Investigational Site Number :8400022
    • California
      • Los Angeles, California, United States, 90027
        • Investigational Site Number :8400023
      • Los Angeles, California, United States, 90048
        • Investigational Site Number :8400033
      • Sacramento, California, United States, 95817
        • Investigational Site Number :8400005
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8017
        • Investigational Site Number :8400029
    • Florida
      • Miami, Florida, United States, 33101
        • Investigational Site Number :8400006
      • Miami, Florida, United States, 33155
        • Investigational Site Number :8400008
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Investigational Site Number :8400020
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Investigational Site Number :8400036
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Investigational Site Number :8400014
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Investigational Site Number :8400015
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Investigational Site Number :8400010
      • Morristown, New Jersey, United States, 07962
        • Investigational Site Number :8400016
    • New York
      • New Hyde Park, New York, United States, 11040
        • Investigational Site Number :8400017
      • New York, New York, United States, 10021
        • Investigational Site Number :8400007
      • Syracuse, New York, United States, 13210
        • Investigational Site Number :8400021
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Investigational Site Number :8400034
      • Greenville, North Carolina, United States, 27834
        • Investigational Site Number :8400025
    • Oregon
      • Portland, Oregon, United States, 97227
        • Investigational Site Number :8400004
      • Portland, Oregon, United States, 97239-3098
        • Investigational Site Number :8400035
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Investigational Site Number :8400028
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Investigational Site Number :8400027
    • Tennessee
      • Nashville, Tennessee, United States, 37292
        • Investigational Site Number :8400024
    • Texas
      • Houston, Texas, United States, 77030
        • Investigational Site Number :8400013
      • Houston, Texas, United States, 77030
        • Investigational Site Number :8400019
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Investigational Site Number :8400026
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Investigational Site Number :8400009
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Investigational Site Number :8400001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

Pharmaceutical form: capsule

Route of administration: oral

Other Names:
  • Hectorol
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.

Pharmaceutical form: capsule

Route of administration: oral

Other Names:
  • Rocaltrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants achieving two consecutive ≥30% reductions in iPTH
Time Frame: Baseline up to Week 12
Baseline up to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage change from baseline in iPTH
Time Frame: Baseline, Week 12, Week 24
Baseline, Week 12, Week 24
Number of hypercalcemia events (albumin corrected serum calcium >10.2 mg/dL)
Time Frame: Up to Weeks 12 and 24
Up to Weeks 12 and 24
Number of participants with adverse events
Time Frame: Baseline up to Week 24
Baseline up to Week 24
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2017

Primary Completion (Anticipated)

November 12, 2025

Study Completion (Anticipated)

November 12, 2025

Study Registration Dates

First Submitted

August 4, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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