NCT02859896

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Secondary Hyperparathyroidism-Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Doxercalciferol (GZ427397)	Pharmaceutical form: capsule Route of administration: oral
DRUG	Calcitriol	Pharmaceutical form: capsule Route of administration: oral

Timeline

• Start date: 2017-01-19
• Primary completion: 2025-06-11
• Completion: 2025-06-11
• First posted: 2016-08-09
• Last updated: 2025-07-29

Locations

23 sites across 2 countries: United States, Chile

Regulatory

• FDA-regulated drug study