At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 14 enrolled
Drug / intervention
burosumabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Single-Arm, Phase 3 Study to Evaluate the Effects of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)
In Brief
A Phase 3 clinical trial evaluating burosumab for X-linked Hypophosphatemia. Completed, enrolled 14 participants across 14 sites in 6 countries.
Detailed Summary
The primary objective of this study is to establish the effect of KRN23 treatment on improvement in XLH-associated osteomalacia as determined by osteoid volume (osteoid volume/bone volume, OV/BV).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsX-linked Hypophosphatemia
CountriesCanada, Denmark, France, Japan, South Korea, United States
CollaboratorsKyowa Kirin Co., Ltd.
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartDec 2015
Primary CompletionAug 2017
Study CompletionDec 2018
TodayJul 2026
First PostedSep 1, 2015
Enrollment StartDec 23, 2015
Primary CompletionAug 30, 2017
Study CompletionDec 13, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.8 years ago
Interventions
burosumabbiological
solution for subcutaneous injection