Last updated on December 2018

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


Brief description of study

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.

Clinical Study Identifier: NCT02915705

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Children's Hospital Los Angeles

Los Angeles, CA United States

UCSF

San Francisco, CA United States

Indiana University School of Medicine

Indianapolis, IN United States

Shriners Hospital For Children

Saint Louis, MO United States

Vanderbilt University Medical Center

Nashville, TN United States

SickKids

Toronto, ON Canada

ODense University Hospital

Odense C, Denmark

University of Florence

Florence, Italy

Osaka University Hospital

Suita-shi, Japan

Seoul National University Hospital

Seoul, Korea, Republic of

Birmingham Children's Hospital

Birmingham, United Kingdom

Recruitment Status: Closed


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