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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031605
Receipt No. R000036050
Scientific Title Study of longitudinal observation for patient with X-linked hypophosphatemic rickets/osteomalacia in collaboration with Asian partners
Date of disclosure of the study information 2018/04/20
Last modified on 2020/09/16

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Basic information
Public title Study of longitudinal observation for patient with X-linked hypophosphatemic rickets/osteomalacia in collaboration with Asian partners
Acronym SUNFLOWER Study
Scientific Title Study of longitudinal observation for patient with X-linked hypophosphatemic rickets/osteomalacia in collaboration with Asian partners
Scientific Title:Acronym SUNFLOWER Study
Region
Japan Asia(except Japan)

Condition
Condition X-linked hypophosphatemic rickets/osteomalacia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Through observation of patients with X-linked hypophosphatemic rickets/osteomalacia (XLH) for up to 5 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
Basic objectives2 Others
Basic objectives -Others -
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Patients aged,<18years:Height,Rickets Severity Score,QOL,and motor function Patients aged >=18years:QOL and motor function
Key secondary outcomes Patients aged <18 years:Growth velocity, lower limb deformity,biomarkers for phosphorus metabolism and bone metabolism,and fracture
Patients aged >=18 years:Biomarkers for phosphorus metabolism and bone metabolism,fracture,spinal ligament ossification,nephrocalcinosis,and renal function

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with a diagnosis of XLH who fulfil all of the following criteria:
1. Patients must meet at least one of the following:
(1) Documented PHEX gene mutation
(2) Documented PHEX gene mutation in at least one family member with X-linked genetic relationship
(3) Documented FGF23 >30 pg/mL
2. Typical clinical findings of rickets/osteomalacia in the past or present
3. Written informed consent obtained from patients aged >=20 years or from parents or legally acceptable representatives of patients aged <20 years
Key exclusion criteria 1. Participation in any clinical study (trial) sponsored by Kyowa Kirin at the time of informed consent
2. Any patient whose participation in the study is considered inappropriate by the investigator or the subinvestigator
Target sample size 160

Research contact person
Name of lead principal investigator
1st name Keiichi
Middle name
Last name Ozono
Organization Osaka University Graduate School of Medicine
Division name Pediatrics
Zip code 565-0871
Address 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-5111
Email keioz@ped.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Etsuou
Middle name
Last name Imai
Organization SRD Co., Ltd.
Division name Clinical Research Department
Zip code 104-0032
Address 3-4-8 Hatchobori, Chuo-ku, Tokyo 104-0032, Japan
TEL 03-5543-0302
Homepage URL
Email khk-xlh@cro-srd.co.jp

Sponsor
Institute Kyowa Kirin Co., Ltd.
Institute
Department

Funding Source
Organization Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Review Board of Osaka University Hospital
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
Tel 06-6210-8296
Email rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 20 Day

Related information
URL releasing protocol https://bmjopen.bmj.com/content/10/6/e036367
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 31 Day
Date of IRB
2018 Year 03 Month 06 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design:
Prospective cohort study

Study period:
April 2018 to December 2023

Methodology:
Patients who have given written informed consent to participation in the study will be registered in the EDC. Data of routine clinical examination and observation will be entered and if patients cooperate, study-specific assessments (blood sampling, questionnaire, motor function test, and anthropometric measurement) will be performed. In case of changes of residence or hospital during the observation period, additional consent will be optionally obtained from patients to allow follow-up by the Follow-up Center.

Management information
Registered date
2018 Year 03 Month 06 Day
Last modified on
2020 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036050

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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