UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056703 |
|---|---|
| Receipt number | R000063867 |
| Scientific Title | Development of genetic testing and analysis methods for the onset and progression of chronic kidney disease |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/06/25 12:22:01 |
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Basic information
Public title
Development of genetic testing and analysis methods for the onset and progression of chronic kidney disease
Acronym
Development of genetic testing methods for chronic kidney disease
Scientific Title
Development of genetic testing and analysis methods for the onset and progression of chronic kidney disease
Scientific Title:Acronym
Development of genetic testing methods for chronic kidney disease
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To develop a testing method for rapid and accurate genetic testing related to chronic kidney disease.
Basic objectives2
Others
Basic objectives -Others
To evaluate the effectiveness of the testing method, the study will assess the time from blood sample collection to obtaining necessary results, the accuracy of the results, and the yield rate, defined as the proportion of cases where all required results are successfully obtained.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of known pathogenic variants associated with chronic kidney disease
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants who have demonstrated understanding of the informed consent document, which includes the details of this study, and have voluntarily provided their consent.
Key exclusion criteria
Individuals deemed unsuitable for participation in the study based on the physician's judgment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Okada |
Organization
Saitama Medical University
Division name
Nephrology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1611
hirookda@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Inoue |
Organization
Saitama Medical University
Division name
Nephrology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1611
Homepage URL
t_inoue@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Hospital
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
Tel
049-276-1354
hirb@saitama-med.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
| 2025 | Year | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an investigation of genetic testing methods using human blood samples, and no specific outcome measure has been set.
Management information
Registered date
| 2025 | Year | 01 | Month | 14 | Day |
Last modified on
| 2025 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063867
