NCT03233126

A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia

A Phase 3 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia and a Postmarketing Study of KRN23 Switched From the Phase 3 Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

Before switching to the post-marketing study: To evaluate the efficacy and safety of KRN23 administered subcutaneously once every 2 weeks in children with X-linked hypophosphatemic rickets/osteomalacia(XLH). After switching to the post-marketing study: To evaluate the safety and efficacy of KRN23, which is switched from the investigational product to the post-marketing study drug, at the approved dose and dosing regimen in subjects who continue treatment

Conditions

• X-linked Hypophosphatemic Rickets/Osteomalacia

Interventions

Type	Name	Description
DRUG	KRN23	Subjects will receive subcutaneous injections of KRN23 every 2 weeks from Week 0 through Week 86

Timeline

• Start date: 2017-07-06
• Primary completion: 2020-02-17
• Completion: 2020-02-17
• First posted: 2017-07-28
• Last updated: 2022-09-06

Locations

4 sites across 1 country: Japan