drugset / Trial / NCT03233126

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

NCT03233126

Phase 3 Completed 16 enrolled Kyowa Kirin, Inc.
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2017-07-06
Primary completion
2020-02-17
Completion
2020-02-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Burosumab Monoclonal antibody 0.8 mg/kg Subcutaneous