The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
University of California San Francisco
San Francisco, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Clinical Research Center, Indiana University School of Medicine
Indianapolis, Indiana, United States
Duke Clinical Research Unit
Durham, North Carolina, United States
Safety and Efficacy of Repeated SC Injections of KRN23.
Safety and efficacy of repeated SC injections of KRN23, from Baseline, as assessed by serum phosphorus levels, immunogenicity, adverse events and clinically significant changes in vital signs and laboratory testing.
Time frame: 13.5 months,(50 visits)
Evaluation of Effect of Repeated SC Injections of KRN23
Effect of repeated SC injections of KRN23, from baseline, on pharmacodynamic parameters (serum phosphorus)
Time frame: 13.5 months, (50 visits)
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University of Texas Health Science Center at Houston
Houston, Texas, United States
Shriners Hospital for Children - Canada
Montreal, Quebec, Canada