Last updated on September 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

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San Francisco, CA United States

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Indiana University School of Medicine
Indianapolis, IN United States

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Shriners Hospital For Children
Saint Louis, MO United States

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Vanderbilt University Medical Center
Nashville, TN United States

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Sydney Children's Hospital Network
Westmead, Australia

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Children's Hospital of Eastern Ontario (CHEO) Research Institute
Ottowa, ON Canada

Etienne Sochett

Toronto, ON Canada

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Shriners Hospital for Children - Canada
Montreal, QC Canada

Henrik Christesen

ODense University Hospital
Odense C, Denmark

Jorg Semler

Children's Hospital University Cologne
Cologne, Germany

Klaus Mohnike

Universitaetsklinikum Magdeburg A. oe. R.-Otto-von-Guericke Universty
Magdeburg, Germany

Ciara McDonnell

Children's University Hospital
Dublin, Ireland

Maria Luisa Brandi

University of Florence
Florence, Italy

Stefano Mora

(IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, Italy

Maria Luisa Bianchi

IRCCS Istituto Auxologico Italiano
Milan, Italy

Giampiero Baroncelli

U.O. Pediatria 1, AOUP
Pisa, Italy

Takashi Hamajima

Aichi Chidren's Medical Center
Obu, Japan

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Hyogo Prefectural Kobe Children's Hospital
Kobe, Japan

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Kanagawa Children's Medical Center
Yokohama, Japan

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Osaka University Hospital
Suita-shi, Japan

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Okayama Saiseikai General Hospital
Okayama, Japan

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Japan Community Healthcare Organization Osaka Hospital
Osaka, Japan

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National Center for Child Health and Development
Tokyo, Japan

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Seoul National University Hospital
Seoul, Korea, Republic of

Gabriel Martos-Moreno

Hospital Infantil Universitario Ni o Jes s
Madrid, Spain

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Karolinska Institutet and University Hospital
Stockholm, Sweden

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Birmingham Children's Hospital
Birmingham, United Kingdom

Raja Padidela

Royal Manchester Children's Hospital - University of Manchester
Manchester, United Kingdom