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

ID: NCT02859896
Status: Recruiting
Phase: Phase 3
Start Date: January 19, 2017
First Submitted: August 04, 2016
Last Updated: February 22, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi
Location: Chile, United States
Conditions: Secondary Hyperparathyroidism-Chronic Kidney Disease
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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.
Condition or disease Intervention/treatment Phase

Secondary Hyperparathyroidism-Chronic Kidney Disease

Drug: Doxercalciferol (GZ427397)
Other Names
Hectorol
Drug: Calcitriol
Other Names
Rocaltrol
Phase 3

Tracking Information

First Submitted DateAugust 04, 2016
Last Update Posted DateFebruary 22, 2018
Actual Start DateJanuary 19, 2017
Anticipated Completion DateApril 02, 2020
Actual Primary Completion DateDecember 27, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Percentage change from baseline in iPTH [Time Frame: 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]

  • Number of participants with adverse events [Time Frame: 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]

Original Secondary Outcome Measures

Not Available

Study Design

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

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.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
84
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Secondary Hyperparathyroidism-Chronic Kidney Disease
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Doxercalciferol (GZ427397)

Pharmaceutical form: capsule Route of administration: oral

Other Names
Hectorol
Drug: Calcitriol

Pharmaceutical form: capsule Route of administration: oral

Other Names
Rocaltrol
Study Groups/Cohorts
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.

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.

Study Arms
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.
Drug : Doxercalciferol (GZ427397)
Pharmaceutical form: capsule Route of administration: oral

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.
Drug : Calcitriol
Pharmaceutical form: capsule Route of administration: oral

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.
Drug : Doxercalciferol (GZ427397)
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.
Drug : Calcitriol

Recruitment Information

Recruitment Status:Recruiting
Enrollment84
Completion DateApril 02, 2020
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.
GenderAll
Age5 Years to 18 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Chile
United States
Argentina

Administrative Information

NCT Number:NCT02859896
Other Study ID Numbers
LPS14314
U1111-1178-4657
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Not Available
Investigators
Study Director
Clinical Sciences & Operations
Sanofi