drugset / Trial / NCT04308096

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

NCT04308096

Phase 3 Completed 27 enrolled Kyowa Kirin, Inc.
NaSingle-groupOpen-labelTreatment

Summary

Before switching to the post-marketing study: Assess the efficacy and safety of KRN23 administered subcutaneously once every 4 or 2 weeks in adult or children with XLH After switching to the post-marketing study: To evaluate the safety and efficacy of KRN23, which was switched from the investigational product to the post-marketing investigational product, at the approved dose and dosing regimen in subjects who continued treatment

Timeline

Start
2018-01-09
Primary completion
2020-12-04
Completion
2020-12-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Burosumab Monoclonal antibody 0.8 mg/kg Subcutaneous
Subject Burosumab Monoclonal antibody 1 mg/kg Subcutaneous