A Study of KRN23 in X-linked Hypophosphatemia

Completed · Phase 1 · Has a placebo group

Conditions studied: X-linked Hypophosphatemia

In brief

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.

Key facts

Study ID

NCT00830674

Run by

Kyowa Kirin Co., Ltd.

People needed

42

Starts

2008-12-01

Expected to finish

2013-05-01

Last updated by the study team

2024-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older
• Clinical diagnosis of XLH
• TmP/GFR is less than 2.0 mg/dL
• GFR is 60 mL/min or above

You may not qualify if…

• 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

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States
• General Clinical Research Center, Indiana University School of Medicine — Indianapolis, Indiana, United States
• Duke Clinical Research Unit — Durham, North Carolina, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.