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 |
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
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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505 Parnassus Ave
San Francisco, California 94143
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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