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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)

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Trial Profile

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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Sep 2024

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At a glance

  • Drugs Burosumab (Primary) ; Alfacalcidol; Calcitriol; Potassium phosphate; Vitamin D
  • Indications X-linked dominant hypophosphataemic rickets
  • Focus Registrational; Therapeutic Use
  • Acronyms PIXLES
  • Sponsors Kyowa Kirin; Ultragenyx Pharmaceutical

    • Most Recent Events

    • 12 Apr 2023 Results of sub group analysis assessing analysis to determine whether skeletal responses differed when switching to burosumab versus continuing higher or lower doses of conventional therapy published in the Journal of Clinical Endocrinology and Metabolism
    • 09 May 2022 Results of a post hoc analysis assessed the impact of age on burosumab efficacy and safety in X-linked hypophosphatemia published in the Journal of Clinical Endocrinology and Metabolism
    • 01 Jul 2021 Results assessing the reliability, validity, and sensitivity to change of the RGI-C were evaluated using data from two studies (NCT02163577, NCT02915705) in pediatric XLH published in the Bone

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