CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Burosumabbiological
Likely dose
Burosumab solution for subcutaneous injection (specific dose not stated in provided text)AI-extracted
Key inclusion· 5
  • ✓Age 1 to <5 years
  • ✓Confirmed XLH diagnosis via PHEX mutation or elevated FGF23 >30 pg/mL
  • ✓Serum phosphorus <3.0 mg/dL
  • ✓Serum creatinine within age-adjusted normal range
Key exclusion· 6
  • ✕Unwilling to discontinue oral phosphate and/or vitamin D metabolites (calcitriol, alfacalcidol)
  • ✕Nephrocalcinosis grade 4 (stone formation) on renal ultrasound
  • ✕Planned or recommended orthopedic surgery (staples, 8-plates, osteotomy) within study period
  • ✕Serum calcium outside age-adjusted normal limits (hypocalcemia or hypercalcemia)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02750618
NCT02750618Phase 2Completed
CompareCT.gov

An Open-Label, Phase 2 Study to Assess the Safety, Pharmacodynamics, and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)

Kyowa Kirin, Inc.·interventional·Posted Apr 25, 2016·Updated May 6, 2024

In Brief

A Phase 2 clinical trial evaluating Burosumab for X-Linked Hypophosphatemia. Completed, enrolled 13 participants across 3 sites.

Detailed Summary

The primary objectives of the study are to: * Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and 4 years old * Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers that reflect the status of phosphate homeostasis in children between 1 and 4 years old with XLH

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsX-Linked Hypophosphatemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 25, 2016
Enrollment StartMay 5, 2016
Primary CompletionApr 20, 2017
Study CompletionSep 10, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 10.2 years ago

Interventions

Burosumabbiological

solution for subcutaneous injection