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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028891
Receipt No. R000033064
Scientific Title The investigation of FGF23, a prognostic factor in children with chronic kidney disease and bone metabolism
Date of disclosure of the study information 2017/08/30
Last modified on 2018/09/05

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Basic information
Public title The investigation of FGF23, a prognostic factor in children with chronic kidney disease and bone metabolism
Acronym The investigation of FGF23 and bone metabolism in children with CKD
Scientific Title The investigation of FGF23, a prognostic factor in children with chronic kidney disease and bone metabolism
Scientific Title:Acronym The investigation of FGF23 and bone metabolism in children with CKD
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Nephrology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the risk factors for elevating FGF23 in children with CKD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Increase or decrease and the balance of FGF23 production and degradation
Key secondary outcomes The extent of sexual maturation, bone metabolism, iron metabolism, inflammation 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
1 years-old <=
Age-upper limit
16 years-old >=
Gender Male and Female
Key inclusion criteria Patients with chronic kidney disease (including renal transplant recipients)
Key exclusion criteria The patients who does not agree with this study. The patients with anemia whose Hb levels are less than 8 g/dl
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsusuke Yamamoto
Organization Osaka Women's and Children's Hospital
Division name Department of Pediatric Nephrology and Metabolism
Zip code
Address 840, Murodo-cho, Izumi city, Osaka
TEL 0725561220
Email dr-katz@jt8.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Natsumi Yamamura
Organization Osaka Women's and Children's Hospital
Division name Department of Pediatric Nephrology and Metabolism
Zip code
Address 840, Murodo-cho, Izumi city, Osaka
TEL 0725561220
Homepage URL
Email yamamur@mch.pref.osaka.jp

Sponsor
Institute Osaka Women's and Children's Hospital
Institute
Department

Funding Source
Organization Osaka Public Health Association
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 08 Month 30 Day

Related information
URL releasing protocol
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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective observational study

Management information
Registered date
2017 Year 08 Month 29 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033064

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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