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: Drug: Doxercalciferol (GZ427397); Drug: Calcitriol

• 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.

Study Timeline

• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Study Start: 2017-01-19
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27
• Primary Completion: 2025-11-12
• Study Completion: 2025-11-12

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

Group	Intervention	Description
Hectorol	Doxercalciferol (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.
Rocaltrol	Calcitriol	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.

Primary Outcome Measures

Name	Time	Method
Percentage of participants achieving two consecutive ≥30% reductions in iPTH	Baseline up to Week 12

Secondary Outcome Measures

Name	Time	Method
Assessment of pharmacokinetic (PK) parameter: Serum 1,25-dihydroxyvitamin D2 concentration-time data	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
Percentage change from baseline in iPTH	Baseline, 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 events	Baseline up to Week 24

Trial Locations

Locations (30)

Investigational Site Number :8400022; 🇺🇸 Birmingham, Alabama, United States

Investigational Site Number :8400023; 🇺🇸 Los Angeles, California, United States

Investigational Site Number :8400033; 🇺🇸 Los Angeles, California, United States

Investigational Site Number :8400005; 🇺🇸 Sacramento, California, United States

Investigational Site Number :8400029; 🇺🇸 New Haven, Connecticut, United States

Investigational Site Number :8400006; 🇺🇸 Miami, Florida, United States

Investigational Site Number :8400008; 🇺🇸 Miami, Florida, United States

Investigational Site Number :8400020; 🇺🇸 Chicago, Illinois, United States

Investigational Site Number :8400036; 🇺🇸 Indianapolis, Indiana, United States

Investigational Site Number :8400014; 🇺🇸 Minneapolis, Minnesota, United States

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