An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia

Completed · Phase 1/Phase 2

Conditions studied: X-linked Hypophosphatemia

In brief

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).

Key facts

Study ID

NCT01571596

Run by

Kyowa Kirin Co., Ltd.

People needed

23

Starts

2012-02-01

Expected to finish

2014-06-01

Last updated by the study team

2024-06-18

Who can join

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

You may qualify if…

• Satisfactory completion of KKP's sponsored KRN23-INT-001 clinical trial
• eGFR ≥ 60 mL/min
• Corrected Ca < 10.8 mg/dL
• For female of child-bearing potential, a negative serum pregnancy test
• A willingness to utilize adequate contraception and not become pregnant [or to have their partner(s) become pregnant] during the study
• Additional inclusion criteria apply

You may not qualify if…

• Subject experienced a safety-related event in the KRN23-INT-001 study
• Pregnant or lactating female subject or pregnant or female planning to become pregnant during the study
• Receipt of a live (attenuated) vaccine (except for influenza vaccines) during the course of the KRN23-INT-001 study and/or of this study
• Condition which could present a concern for either the subject's safety or difficulty with data interpretation
• Additional exclusion criteria apply

Where it is running

• University of California San Francisco — San Francisco, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• 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
• Shriners Hospital for Children - Canada — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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