A Repeated Study of KRN23 in Adults With X-Linked Hypophosphatemia



Status:Completed
Conditions:Other Indications, Metabolic
Therapuetic Areas:Pharmacology / Toxicology, Other
Healthy:No
Age Range:18 - Any
Updated:10/19/2013
Start Date:April 2011
End Date:November 2013
Contact:Amy Zhang, PhD
Email:azhang@kyowa-kirin-pharma.com
Phone:609-919-1100

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A Phase I/II, Open-Label, Repeat-Dose, Dose-Escalation Study of KRN23 in Adult Subjects 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 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
We found this trial at
5
sites
505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
1343
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San Francisco, CA
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
563
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Houston, TX
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Durham, North Carolina 27710
1052
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Durham, NC
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643
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Indianapolis, IN
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
1344
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New Haven, CT
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