NCT02915705

Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With XLH

A Randomized, Open-Label, Phase 3 Study to Assess the Efficacy and Safety of KRN23 Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With X Linked Hypophosphatemia (XLH)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the effect of KRN23 (burosumab) therapy in improving rickets in children with XLH compared with active control (oral phosphate/active vitamin D).

Conditions

• X-Linked Hypophosphatemia

Interventions

Type	Name	Description
BIOLOGICAL	burosumab	solution for subcutaneous (SC) injection
DRUG	Oral Phosphate Supplement	oral tablet; oral solution; oral powder
DRUG	active vitamin D	tablet, oral solution

Timeline

• Start date: 2016-09-08
• Primary completion: 2018-02-12
• Completion: 2019-07-15
• First posted: 2016-09-27
• Last updated: 2024-08-29
• Results posted: 2019-04-11

Locations

16 sites across 7 countries: United States, Australia, Canada, Japan, South Korea, Sweden, United Kingdom