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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

Primary Purpose

Secondary Hyperparathyroidism-Chronic Kidney Disease

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Doxercalciferol (GZ427397)
Calcitriol
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism-Chronic Kidney Disease

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number :8400022
  • Investigational Site Number :8400023
  • Investigational Site Number :8400033
  • Investigational Site Number :8400005
  • Investigational Site Number :8400029
  • Investigational Site Number :8400006
  • Investigational Site Number :8400008
  • Investigational Site Number :8400020
  • Investigational Site Number :8400036
  • Investigational Site Number :8400014
  • Investigational Site Number :8400015
  • Investigational Site Number :8400010
  • Investigational Site Number :8400016
  • Investigational Site Number :8400017
  • Investigational Site Number :8400007
  • Investigational Site Number :8400021
  • Investigational Site Number :8400034
  • Investigational Site Number :8400025
  • Investigational Site Number :8400004
  • Investigational Site Number :8400035
  • Investigational Site Number :8400028
  • Investigational Site Number :8400027
  • Investigational Site Number :8400024
  • Investigational Site Number :8400013
  • Investigational Site Number :8400019
  • Investigational Site Number :8400026
  • Investigational Site Number :8400009
  • Investigational Site Number :8400001
  • Investigational Site Number :1520004
  • Investigational Site Number :1520003

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hectorol

Rocaltrol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Percentage of participants achieving two consecutive ≥30% reductions in iPTH

Secondary Outcome Measures

Percentage change from baseline in iPTH
Number of hypercalcemia events (albumin corrected serum calcium >10.2 mg/dL)
Number of participants with adverse events
Assessment of pharmacokinetic (PK) parameter: Serum 1,25-dihydroxyvitamin D2 concentration-time data

Full Information

First Posted
August 4, 2016
Last Updated
April 26, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02859896
Brief Title
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 19, 2017 (Actual)
Primary Completion Date
November 12, 2025 (Anticipated)
Study Completion Date
November 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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®.
Detailed Description
The total study duration per patient will be approximately up to 28 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism-Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hectorol
Arm Type
Experimental
Arm Description
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.
Arm Title
Rocaltrol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Doxercalciferol (GZ427397)
Other Intervention Name(s)
Hectorol
Intervention Description
Pharmaceutical form: capsule Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Other Intervention Name(s)
Rocaltrol
Intervention Description
Pharmaceutical form: capsule Route of administration: oral
Primary Outcome Measure Information:
Title
Percentage of participants achieving two consecutive ≥30% reductions in iPTH
Time Frame
Baseline up to Week 12
Secondary Outcome Measure Information:
Title
Percentage change from baseline in iPTH
Time Frame
Baseline, Week 12, Week 24
Title
Number of hypercalcemia events (albumin corrected serum calcium >10.2 mg/dL)
Time Frame
Up to Weeks 12 and 24
Title
Number of participants with adverse events
Time Frame
Baseline up to Week 24
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :8400022
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Investigational Site Number :8400023
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Investigational Site Number :8400033
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Investigational Site Number :8400005
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Investigational Site Number :8400029
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8017
Country
United States
Facility Name
Investigational Site Number :8400006
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
Facility Name
Investigational Site Number :8400008
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Investigational Site Number :8400020
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Investigational Site Number :8400036
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Investigational Site Number :8400014
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Investigational Site Number :8400015
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Investigational Site Number :8400010
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Investigational Site Number :8400016
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Investigational Site Number :8400017
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Investigational Site Number :8400007
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Investigational Site Number :8400021
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Investigational Site Number :8400034
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Investigational Site Number :8400025
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Investigational Site Number :8400004
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Investigational Site Number :8400035
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Investigational Site Number :8400028
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Investigational Site Number :8400027
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Investigational Site Number :8400024
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37292
Country
United States
Facility Name
Investigational Site Number :8400013
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site Number :8400019
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site Number :8400026
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Investigational Site Number :8400009
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Investigational Site Number :8400001
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Investigational Site Number :1520004
City
Concepción
State/Province
Biobío
Country
Chile
Facility Name
Investigational Site Number :1520003
City
Santiago
State/Province
Reg Metropolitana De Santiago
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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