A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia
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).
 A Bone Substudy will evaluate the effects of single-blind KRN23 versus Placebo on bone
 mineral density and bone quality.
Main Inclusion Criteria:

 1. 18 years or older

 2. Clinical diagnosis of XLH

 3. TmP/GFR < 2.0 mg/dL

 4. GFR ≥60 mL/min

 5. Corrected Ca <10.8 mg/dL

 6. A willingness to utilize adequate contraception and not become pregnant[or to have
 their partner(s) become pregnant] during the study

 7. Additional inclusion criteria apply

 Main Exclusion Criteria:

 1. Have any sign of active infectious disease or have had an infection requiring
 treatment with antibiotics within 3-weeks of Screening

 2. History of known immunodeficiency

 3. Pregnant or lactating females subjects or female planning to be become pregnant during
 the study

 4. Receipt of a live (attenuated) vaccine (except for influenza vaccines) within 3-months
 of Screening, and/or during the study

 5. Use of pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and
 ingestion of aluminum hydroxide antacids within 10-days prior to Screening and/or
 dosing

 6. Use of any supplement containing phosphate, calcium and/or vitamin D within 10-days
 prior to Screening and/or dosing

 7. Condition which could present a concern for either the subject's safety or difficulty
 with data interpretation

 8. Additional exclusion criteria apply