Clinical Trial: Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional




Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of KRN23 in Adults With X-linked Hypophosphatemia (XLH)

Brief Summary: UX023-CL303 is a phase 3 multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of KRN23 in adult subjects with XLH. Approximately 120 subjects with a diagnosis of XLH supported by clinical and biochemical features consistent with XLH and/or a confirmed PHEX mutation (self or family member consistent with X-linked inheritance) and with bone or joint pain at baseline will be enrolled. Subjects not receiving supplementation therapy with oral phosphate and active vitamin D metabolites or those willing to discontinue supplementation therapy are eligible.