Last updated on May 2017

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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UCSF
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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
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Etienne Sochett

SickKids
Toronto, ON Canada
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Shriners Hospital for Children - Canada
Montreal, QC Canada
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Henrik Christesen

ODense University Hospital
Odense C, Denmark
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Jorg Semler

Children's Hospital University Cologne
Cologne, Germany
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Klaus Mohnike

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

Children's University Hospital
Dublin, Ireland
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Maria Luisa Brandi

University of Florence
Florence, Italy
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Stefano Mora

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

IRCCS Istituto Auxologico Italiano
Milan, Italy
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Giampiero Baroncelli

U.O. Pediatria 1, AOUP
Pisa, Italy
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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
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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
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Raja Padidela

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