Status:
COMPLETED
A Study of KRN23 in X-linked Hypophosphatemia
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Collaborating Sponsors:
Kyowa Hakko Kirin Pharma, Inc.
Conditions:
X-linked Hypophosphatemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to assess the safety and tolerability of KRN23 after a single intravenous (IV) and subcutaneous (SC) administration in XLH patients.
Eligibility Criteria
Inclusion
- 18 years or older
- Clinical diagnosis of XLH
- TmP/GFR is less than 2.0 mg/dL
- GFR is 60 mL/min or above
Exclusion
- Have any sign of active infectious disease or have had an infection requiring treatment with antibiotics within three weeks prior to screening
- History of known immunodeficiency
- Lactating females, female patients who are pregnant or planning to become pregnant during the study
- Use of a pharmacologic vitamin D metabolite or its analog, phosphate, calcimimetics, and ingestion of aluminum hydroxide antacids within 10 days prior to screening and dosing
- Use of any supplement contained phosphate, calcium and/or vitamin D within 10 days prior to screening and dosing
- Receipt of live (attenuated) vaccine within 3-months prior to screening
- Have any condition which, in the opinion of the Investigator, could present a concern for either patient safety or difficulty with data interpretation
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00830674
Start Date
December 1 2008
End Date
May 1 2013
Last Update
June 17 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
2
General Clinical Research Center, Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202-5250
3
Duke Clinical Research Unit
Durham, North Carolina, United States, 27710
4
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030