CompletedPhase 1/2

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

United States23 participantsStarted 2012-02

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Safety and Efficacy of Repeated SC Injections of KRN23.

Timeframe: 13.5 months,(50 visits)

Trial details

NCT IDNCT01571596

SponsorKyowa Kirin Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-09

Results submitted2020-10-08

View on ClinicalTrials.gov More X-linked Hypophosphatemia trials