UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060539 |
|---|---|
| Receipt number | R000069251 |
| Scientific Title | Clinicopathological Analysis of Renal Fibrosis-Related Molecules Using Human Kidney Biopsy Specimens |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/01/31 20:48:14 |
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Basic information
Public title
Clinicopathological Analysis of Renal Fibrosis-Related Molecules Using Human Kidney Biopsy Specimens
Acronym
Clinicopathological Analysis of Renal Fibrosis-Related Molecules Using Human Kidney Biopsy Specimens
Scientific Title
Clinicopathological Analysis of Renal Fibrosis-Related Molecules Using Human Kidney Biopsy Specimens
Scientific Title:Acronym
Clinicopathological Analysis of Renal Fibrosis-Related Molecules Using Human Kidney Biopsy Specimens
Region
| Japan |
Condition
Condition
Chronic Kidney Disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the molecular pathological association between renal interstitial fibrosis, renal function indices (e.g., eGFR), and the expression of fibrosis-related molecules using archived human kidney biopsy specimens.
Basic objectives2
Others
Basic objectives -Others
Kidney biopsy specimens will be immunostained using glucose metabolism-related molecules as primary markers. The expression levels of these molecules and fibrosis indices will be comprehensively analyzed to examine their association with eGFR at the time of biopsy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between expression levels of glucose metabolism-related molecules by immunostaining, fibrosis indices, and eGFR slope
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
Eligible participants are adult patients (>=18 years old) with chronic kidney disease, regardless of sex, who are judged by the principal or co-investigators to fulfill all of the following criteria:
Diagnosed with a major renal disease such as diabetic kidney disease, nephrosclerosis, or IgA nephropathy.
Kidney biopsy specimens have been appropriately fixed and preserved, allowing for immunohistochemical assessment.
Clinical laboratory data are documented in the electronic medical records.
Key exclusion criteria
Cases where immunohistochemical evaluation is not feasible due to insufficient biopsy specimen quantity or inadequate preservation.
Cases with significant gaps in follow-up data that prevent assessment of renal function progression.
Cases with an unconfirmed or unclassifiable histopathological diagnosis (cases potentially requiring future re-evaluation of kidney biopsy findings are excluded from this study).
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Okada |
Organization
Saitama Medical University Hospital
Division name
Department of Nephrology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1611
okada.hirokazu@1972.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Okada |
Organization
Saitama Medical University Hospital
Division name
Department of Nephrology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL
049-276-1611
Homepage URL
okada.hirokazu@1972.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
okada.hirokazu@1972.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
| 2026 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing in particular
Management information
Registered date
| 2026 | Year | 01 | Month | 31 | Day |
Last modified on
| 2026 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069251
