Active — Not RecruitingNot Applicable

Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners

Japan226 participantsStarted 2018-05-01

Plain-language summary

Through observation of patients with X-linked hypophosphatemic rickets/osteomalacia (XLH) for up to 10 years, the study intends to collect data that allow achievement of the following objectives: 1. To determine medical characteristics of the disease and the disease process 2. To determine physical and psychological burden on patients as well as economic burden 3. To assess the efficacy and safety of the treatment of the disease

Who can participate

SexALL

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Inclusion criteria

✓. Documented PHEX gene mutation
✓. Documented PHEX gene mutation in at least one family member with X-linked genetic relationship
✓. Documented FGF23 \>30 pg/mL

What they're measuring

Height

Timeframe: After enrollment, patients will be observed annually or every 2 years for up to 10 years.

The 6-Minutes Walking Test

Timeframe: After enrollment, patients will be observed annually for up to 10 years.

Timed Up and Go Test(TUGT)

Timeframe: After enrollment, patients will be observed every 2 years for up to 10 years.

Trial details

NCT IDNCT03745521

SponsorKyowa Kirin Co., Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-12-31

View on ClinicalTrials.gov More X-Linked Hypophosphatemia trials