CompletedPhase 1

A Study of KRN23 in X-linked Hypophosphatemia

United States42 participantsStarted 2008-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Safety and tolerability

Timeframe: Up to 7 weeks after dosing (maximally 11 weeks)

Trial details

NCT IDNCT00830674

SponsorKyowa Kirin Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-12

View on ClinicalTrials.gov More X-linked Hypophosphatemia trials