UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060704 |
|---|---|
| Receipt number | R000069442 |
| Scientific Title | Observational study about the relationship between intestinal flora,intestinal barrier and kidney function in the chronic kidney disease patients |
| Date of disclosure of the study information | 2026/02/18 |
| Last modified on | 2026/02/18 19:29:07 |
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Basic information
Public title
Observational study about the relationship between intestinal flora,intestinal barrier and kidney function in the chronic kidney disease patients
Acronym
IFBK-CKD
Scientific Title
Observational study about the relationship between intestinal flora,intestinal barrier and kidney function in the chronic kidney disease patients
Scientific Title:Acronym
IFBK-CKD
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the relationship between intestinal flora, metabolite, and factors related with intestinal barrier in the chronic kidney disease (CKD) patients (Stage G1-G5).
Basic objectives2
Others
Basic objectives -Others
It is expected that basic data for inventing the new treatment ways of CKD will be obtained by identifying the relationship between intestinal flora, intestinal barrier and kidney function, and intestinal flora and metabolite related with intestinal barrier and CKD progression.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Investigate the relationship between CKD and intestinal flora, by analyzing CKD Stage, metabolomics of blood, urine and feces, and intestinal flora.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients in nephrology department of Kyoto University Hospital who agree to join this study.
Key exclusion criteria
Patients with severe digestive diseases, cancer, pregnent, or who take antibiotics, immunosuppressant drugs
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Yanagita |
Organization
Kyoto University
Division name
Department of Nephrology, Graduate School of Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3860
motoy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Yamada |
Organization
Kyoto University
Division name
Department of Adaptive and Maladaptive Responses in Health and Disease, Graduate School of Medicine
Zip code
606-8507
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7482
Homepage URL
ryamada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
The other
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
Kyoto University
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
Tel
075-751-3111
ryamada@kuhp.kyoto-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
京都府
Institutions
Institutions
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 18 | 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
| 2025 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study: Prospective case series study.
Research registration: -2027/3/31.
Planned number of people: 180.
Measurement target: blood, urine, feces.
Others: questionnaire, body composition evaluation
Management information
Registered date
| 2026 | Year | 02 | Month | 18 | Day |
Last modified on
| 2026 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069442
