ClinicalTrials.gg
RecruitingNCT06202027Updated Nov 2, 2026

Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients

An observational study in FGF23-related Hypophosphataemic Rickets and Osteomalacia, sponsored by Kyowa Kirin Korea Co., Ltd.. Recruiting at 13 sites in South Korea. Open to participants aged 1 Day and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Kyowa Kirin Korea Co., Ltd. (part of Kyowa Kirin Co., Ltd.) · Observational

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 3 months later.
Updated Nov 2, 2026Study contact changedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
1 Day and older
Sex
All
01

Study summary

The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of CRYSVITA injection 10, 20, and 30mg, equivalent to in routine clinical settings

02

Conditions studied

  • FGF23-related Hypophosphataemic Rickets and Osteomalacia

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03

In context

Osteomalacia

34 studies on the registry are indexed under Osteomalacia; 3 are open to participants now.

This study's planned enrollment of 100 is above the median of 65 across 14 observational studies indexed under Osteomalacia.

Browse Osteomalacia studies →

Lead sponsor

Kyowa Kirin Korea Co., Ltd. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

FGF23-related hypophosphataemic rickets and osteomalacia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients who have been started on CRYSVITA® in accordance with the approved label in Korea
  2. Those (or his/her legal guardian) who have agreed in writing to participate in the survey. Children who have obtained a written consent of his/her legal guardian about participation in this survey. In case of pediatric patient, explain sufficiently what you think the patient can understand. In this case, the legal guardian may provide supplementary explanations of the survey.

Exclusion criteria

Exclusion Criteria:

  1. Patients for whom Burosumab is according local label of CRYSVITA®
  2. Patients who intend to use this drug for other purposes
  3. Patients who participated in pre-market clinical trials with CRYSVITA® (Consecutive investigation method ONLY)
  4. Patients who have been taking this drug before the starting day of this study (Consecutive investigation method ONLY)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
24 Weeks
Patient registry
Yes

Interventions

  • DrugFGF23-related hypophosphataemic rickets and osteomalacia

    FGF23-related hypophosphataemic rickets and osteomalacia

06

What researchers measure

Primary outcomes

  1. safety (Special situation, adverse event, symptom, or disease occuring during treatment with a drug)

    Investigators have to record all events (i.e., all AEs and special situations) in CRFs including undesirable medical findings obtained during the medical examination as well as spontaneous reports from subjects. All AEs occurring for at least 4 weeks after the last dose of CRYSVITA® should be included in this study

    Time frame: 4 weeks after follow up

Secondary outcomes

  1. Serum Phosphorus Concentration

    1\) Change from baseline over time in Serum Phosphorus Concentration (mg/dL), up to Week 24

    Time frame: 24 weeks

  2. 1,25-Dihydroxyvitamin D

    2\) Change from baseline over time in 1,25-Dihydroxyvitamin D, up to Week 24

    Time frame: 24 weeks

07

Study locations

13 of 13 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Contact
Study contact changed: h•••@kyowakirin.com · •••3471→h•••@kyowakirin.com · •••3471. See the current contact
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Contact Study contact changed: h•••@kyowakirin.com · •••3471→h•••@kyowakirin.com · •••3471. See the current contact
    + 2 other changes: verification date and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06202027
Responsible party
Sponsor
First posted
Jan 11, 2024
Start date
Aug 11, 2023
Primary completion
Jun 16, 2031 (estimated)
Completion
Jul 16, 2031 (estimated)
Last update
Nov 2, 2026

Study contacts

Hyejin Noh
Contact
hyejin.noh.2u@kyowakirin.com
+82-10-3378-3471
Hyejin Noh
study director · Kyowa Kirin Korea Co., Ltd.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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