FGF23-related Hypophosphataemic Rickets and OsteomalaciaNCT06202027
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
An observational study of FGF23-related Hypophosphataemic Rickets and Osteomalacia, run by Kyowa Kirin Korea Co., Ltd. at 13 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- FGF23-related Hypophosphataemic Rickets and Osteomalacia
- What is being tested?
- FGF23-related hypophosphataemic rickets and osteomalacia
- How many people
- 100 participants
- Where
- 13 sitesSouth Korea
- Study dates
- 11 Aug 2023to 16 Jul 2031
- How long will I take part?
- 24 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- Child, Adult, Older adult
Study population: FGF23-related hypophosphataemic rickets and osteomalacia
Who may be able to join
- Patients who have been started on CRYSVITA® in accordance with the approved label in Korea
- 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.
Who cannot join
- Patients for whom Burosumab is contraindicated according local label of CRYSVITA®
- Patients who intend to use this drug for other purposes
- Patients who participated in pre-market clinical trials with CRYSVITA® (Consecutive investigation method ONLY)
- Patients who have been taking this drug before the starting day of this study (Consecutive investigation method ONLY)
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
South Korea13 sites, 13 recruiting
- Recruiting
Inje University Busan Paik Hospital
Busan, 47392
Boryeon Lee, +82-51-890-6114, bolyunlee@gmail.com
Boryeon Lee
- Recruiting
Pusan National University Hospital
Busan, 49241
Hayoung Cho, +82-51-240-7298, gocaki_@naver.com
Hayoung Cho
- Recruiting
Chonnam National University Hospital
Gwangju, Jeollanam-do, 61469
Eunmi Yang, +82-62-220-6641, nuts99@naver.com
Eunmi Yang
- Recruiting
Chungnam National University Sejong Hospital
Sejong, Sejong Special Self-Governing City, 30099
Boram Lee, +82-1800-3114, dldpfla1001@gmail.com
YuMi Kim
- Recruiting
Seoul National University Hospital
Seoul, 03080
Eun Young Eom, +82-2-2072-1655, uey77@snu.ac.kr
JungMin Ko
- Recruiting
Seoul National University Hospital
Seoul, 03080
Soyoung Lee, +82-2-2072-1655, sy8761@snu.ac.kr
HeeKyung Kang
- Recruiting
Seoul National University Hospital
Seoul, 03080
ChaeHyun Lim, +82-2-2-2072-1655, chl1111@snu.ac.kr
Seungsin Park
- Recruiting
Severance Hospital
Seoul, 03722
MiSun Park, +82-2-2228-0800, qkraltjsgod@yuhs.ac
JungHwan Seo
- Recruiting
Severance Hospital
Seoul, 03722
Narae Park, +82-2-2228-0800, hellopnrae@yuhs.ac
YuMi Lee
- Recruiting
Korea University Guro Hospital
Seoul, 08308
Hyokyung Nam, +82-2-2626-1932, muguet@korea.ac.kr
Hyokyung Nam
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
HaeSang Lee, +82-31-219-4040, seaon98@ajou.ac.kr
Hae Sang Lee
- Recruiting
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
YongHyuk Kim, +82-33-741-0833, sumergo@yonsei.ac.kr
YongHyuk Kim
- Recruiting
Yangsan Pusan National University Hospital
Yangsan, Gyeongsangnam-do, 50612
YeEun Lee, +82-55-360-3724, lye7259@naver.com
JongKun Jeon
About this study
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
- Being tested
- FGF23-related hypophosphataemic rickets and osteomalacia
- Medical subject headings
- Osteomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FGF23-related hypophosphataemic rickets and osteomalaciaDrug
FGF23-related hypophosphataemic rickets and osteomalacia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks after follow up
Secondary outcomes (2)
Serum Phosphorus Concentration
- Change from baseline over time in Serum Phosphorus Concentration (mg/dL), up to Week 24
Measured: 24 weeks
1,25-Dihydroxyvitamin D
- Change from baseline over time in 1,25-Dihydroxyvitamin D, up to Week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start11 Aug 2023
- Primary completion16 Jun 2031 (estimated)
- Study completion16 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FGF23-related Hypophosphataemic Rickets and OsteomalaciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyejin Noh, Study director, Kyowa Kirin Korea Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202027
- Sponsor's protocol ID
- CRYSVITA PMS
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
- ClinicalTrials.gov ID
- NCT06202027
- Acronym / sponsor ID
- CRYSVITA PMS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kyowa Kirin Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 16 Jun 2031 (estimated)
- Study completion
- 16 Jul 2031 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- FGF23-related hypophosphataemic rickets and osteomalacia
Key inclusion criteria (2 listed)
- Patients who have been started on CRYSVITA® in accordance with the approved label in Korea
- 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.
Key exclusion criteria (4 listed)
- Patients for whom Burosumab is contraindicated according local label of CRYSVITA®
- Patients who intend to use this drug for other purposes
- Patients who participated in pre-market clinical trials with CRYSVITA® (Consecutive investigation method ONLY)
- Patients who have been taking this drug before the starting day of this study (Consecutive investigation method ONLY)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FGF23-related hypophosphataemic rickets and osteomalaciaFGF23-related hypophosphataemic rickets and osteomalacia | Drug | – |
Primary outcome
safety (Special situation, adverse event, symptom, or disease occuring during treatment with a drug)
Time frame: 4 weeks after follow up
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
2 secondary outcomes
Serum Phosphorus Concentration
Time frame: 24 weeks
1,25-Dihydroxyvitamin D
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided. Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hyejin Noh study director
Kyowa Kirin Korea Co., Ltd.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of FGF23-related Hypophosphataemic Rickets and Osteomalacia, run by Kyowa Kirin Korea Co., Ltd. at 13 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyejin Noh (+82-10-3378-3471, hyejin.noh.2u@kyowakirin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety (Special situation, adverse event, symptom, or disease occuring during treatment with a drug) (time frame: 4 weeks after follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.