Skip to main content

X-Linked Hypophosphatemia clinical trials at UCSF
4 in progress, 0 open to new patients

  • Efficacy and Safety of KRN23 Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With X Linked Hypophosphatemia (XLH)

    Sorry, not recruiting here

    UX023-CL301 is a multicenter, randomized, open-label, Phase 3 study comparing the efficacy and safety of KRN23 with active control (oral phosphate/active vitamin D therapy) in children with XLH (aged 1 to ≤12 years) who have radiographic evidence of rickets, open epiphyses, and have received oral phosphate/active vitamin D therapy for ≥ 6-12 consecutive months prior to screening. Approximately 60 subjects will be randomized 1:1 to receive open-label KRN23 administered by subcutaneous injection or oral phosphate and active vitamin D therapy for a total of 64 weeks.

    San Francisco, California and other locations

  • Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH)

    Sorry, accepting new patients by invitation only

    UX023-CL203 is a Phase 2b, open-label, long-term extension study. The study will be conducted in adults to assess the safety and pharmacodynamics of KRN23 administered via subcutaneous injections monthly (every 4 weeks) for a total of 68 weeks. The study will enroll approximately 25 adults with XLH who participated in Kyowa Hakko Kirin Pharma, Inc.'s (KHK's) study KRN23-INT-001 or KRN23-INT-002. Subjects will need to discontinue oral phosphate and vitamin D metabolite therapy prior to enrollment and throughout the duration of the study.

    San Francisco, California and other locations

  • Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

    Sorry, in progress, not accepting new patients

    UX023-CL304 is a Phase 3 open-label, single-arm, multicenter study to establish the effects of KRN23 on bone quality and osteomalacia associated with XLH. Approximately 14 adult subjects with a diagnosis of XLH supported by typical clinical and biochemical features and who have not received oral phosphate and vitamin D therapy in the past two years will be enrolled. Iliac crest bone biopsies will be performed at baseline and end of study. Baseline histologic and histomorphometric assessments of the bone biopsy specimens will be performed as each biopsy is completed to assess sample quality and confirm the presence of osteomalacia in at least 8 subjects.

    San Francisco, California and other locations

  • Study of KRN23, a Recombinant Fully Human Monoclonal Antibody Against FGF23, in Pediatric Subjects With X-linked Hypophosphatemia (XLH)

    Sorry, in progress, not accepting new patients

    UX023-CL201 is a randomized, multicenter, open-label, dose finding, Phase 2 study. The study will be conducted in prepubescent children aged 5-12 years with XLH to assess the pharmacodynamics and safety of KRN23 administered via subcutaneous injections monthly (every 4 weeks) or biweekly (every 2 weeks) for a total of 64 weeks. The study consists of a 16-week individual dose Titration Period, followed by a 48-week Treatment Period. The study will enroll approximately 50 pediatric patients with XLH and radiographic evidence of bone disease. Subjects will need to discontinue oral phosphate and vitamin D metabolite therapy prior to randomization and throughout the duration of the study.

    San Francisco, California and other locations