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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

Phase 3
Active, not recruiting
Conditions
Secondary Hyperparathyroidism-Chronic Kidney Disease
Interventions
Registration Number
NCT02859896
Lead Sponsor
Sanofi
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
84
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
HectorolDoxercalciferol (GZ427397)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.
RocaltrolCalcitriolRocaltrol (Calcitriol) will be administered orally seven days/week. A dose titration scheme is used to individualize the dose to the patient's iPTH management.
Primary Outcome Measures
NameTimeMethod
Percentage of participants achieving two consecutive ≥30% reductions in iPTHBaseline up to Week 12
Secondary Outcome Measures
NameTimeMethod
Assessment of pharmacokinetic (PK) parameter: Serum 1,25-dihydroxyvitamin D2 concentration-time dataAt 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
Percentage change from baseline in iPTHBaseline, Week 12, Week 24
Number of hypercalcemia events (albumin corrected serum calcium >10.2 mg/dL)Up to Weeks 12 and 24
Number of participants with adverse eventsBaseline up to Week 24

Trial Locations

Locations (30)

Investigational Site Number :8400022

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Birmingham, Alabama, United States

Investigational Site Number :8400023

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Los Angeles, California, United States

Investigational Site Number :8400033

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Los Angeles, California, United States

Investigational Site Number :8400005

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Sacramento, California, United States

Investigational Site Number :8400029

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New Haven, Connecticut, United States

Investigational Site Number :8400006

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Miami, Florida, United States

Investigational Site Number :8400008

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Miami, Florida, United States

Investigational Site Number :8400020

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Chicago, Illinois, United States

Investigational Site Number :8400036

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Indianapolis, Indiana, United States

Investigational Site Number :8400014

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Minneapolis, Minnesota, United States

Scroll for more (20 remaining)
Investigational Site Number :8400022
🇺🇸Birmingham, Alabama, United States

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