UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028891 |
|---|---|
| Receipt number | 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 | 2023/09/04 15:52:55 |
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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
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 | Natsumi |
| Middle name | |
| Last name | Yamamura |
Organization
Osaka Women's and Children's Hospital
Division name
Department of Pediatric Nephrology and Metabolism
Zip code
594-1101
Address
840, Murodo-cho, Izumi city, Osaka
TEL
0725561220
yamamur@wch.opho.jp
Public contact
Name of contact person
| 1st name | Natsumi |
| Middle name | |
| Last name | Yamamura |
Organization
Osaka Women's and Children's Hospital
Division name
Department of Pediatric Nephrology and Metabolism
Zip code
594-1101
Address
840, Murodo-cho, Izumi city, Osaka
TEL
0725561220
Homepage URL
yamamur@wch.opho.jp
Sponsor or person
Institute
Osaka Women's and Children's Hospital
Institute
Department
Personal name
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
Institutional Review Boards of Osaka Women's and Children's Hospital
Address
840, Murodo-cho, Izumi city, Osaka
Tel
0725561220
shirano@wch.opho.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
| 2017 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2017 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033064
