At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 61 enrolled
Drug / intervention
burosumab +2 morebiological
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.
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)
In Brief
A Phase 3 clinical trial evaluating burosumab, Oral Phosphate Supplement, and 1 other intervention for X-Linked Hypophosphatemia. Completed, enrolled 61 participants across 16 sites in 7 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsX-Linked Hypophosphatemia
CountriesAustralia, Canada, Japan, South Korea, Sweden, United Kingdom, United States
CollaboratorsKyowa Kirin Co., Ltd.
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartSep 2016
First PostedSep 2016
Primary CompletionFeb 2018
Study CompletionJul 2019
TodayJul 2026
First PostedSep 27, 2016
Enrollment StartSep 8, 2016
Primary CompletionFeb 12, 2018
Study CompletionJul 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.8 years ago
Interventions
burosumabbiological
solution for subcutaneous (SC) injection
Oral Phosphate Supplementdrug
oral tablet; oral solution; oral powder
active vitamin Ddrug
tablet, oral solution