UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059416 |
|---|---|
| Receipt number | R000067941 |
| Scientific Title | A prospective cohort study on predictors of renal function decline in a population at risk for the onset and progression of chronic kidney disease |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/10/15 11:22:35 |
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Basic information
Public title
A prospective cohort study on predictors of renal function decline in a population at risk for the onset and progression of chronic kidney disease
Acronym
A prospective cohort study on predictors of renal function decline in a population at risk for the onset and progression of chronic kidney disease
Scientific Title
A prospective cohort study on predictors of renal function decline in a population at risk for the onset and progression of chronic kidney disease
Scientific Title:Acronym
A prospective cohort study on predictors of renal function decline in a population at risk for the onset and progression of chronic kidney disease
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to identify predictors associated with renal function decline in patients with chronic kidney disease (CKD) or those at risk of developing CKD, such as individuals with diabetes, hypertension, or obesity. We will utilize clinical information obtained in routine medical practice, along with regularly collected blood and urine test data and stored blood samples. Through this approach, we aim to explore useful indicators for the early prediction of CKD progression risk and to generate foundational data for the future implementation of personalized medicine and interventional studies aimed at slowing disease progression.
Basic objectives2
Others
Basic objectives -Others
Identification of predictors associated with renal function decline through comprehensive proteomic analyses of blood and urine samples in patients with CKD or those at risk of CKD.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comprehensive protein profiling in blood and urine using Olink Explore HT in patients with CKD or at risk for CKD
Key secondary outcomes
Annual clinical laboratory data (eGFR, Cr, liver function, HbA1c, blood pressure, lipids, CRP, Na, K, renal injury markers, urinary protein, etc.) and imaging examinations (ABI test, cardiac ultrasound, chest X-ray)
Effects of concomitant medications on renal function decline based on medical records
Associations between multidisciplinary interventions, including nutritional counseling and CKD care guidance, and renal function decline
Information on comorbidities (diabetes mellitus, cardiovascular disease, hypertension, etc.)
Prognostic information (ESKD, cardiovascular events, death)
Baseline information at the time of informed consent (sex, age, medical history, smoking history, body composition, etc.)
Measurement of known biomarkers to evaluate their associations with future renal function decline and cardiovascular events
Genetic factors analyzed using DNA derived from blood cells
RNA and epigenetic markers derived from blood cells
Future omics analyses (proteome, transcriptome, epigenome, etc.) using stored biospecimens
Circulating non-coding RNAs in blood
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
1. Patients visiting the Department of Nephrology, Hypertension, and Endocrinology at Nihon University Itabashi Hospital who are diagnosed with chronic kidney disease, or those with diabetes, hypertension, or obesity who are considered to be at high risk of developing chronic kidney disease in the future (from September 2025 to May 2030).
2. healthy individuals who underwent medical checkups at Hatogaya Hospital
Key exclusion criteria
1. Persons who express their unwillingness to participate in this study.
2. Persons deemed by the principal investigator to be unsuitable for inclusion in this study for any reason.
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kobayashi |
Organization
Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
173-8610
Address
30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo
TEL
+81-3-3972-8111
kobayashi.hiroki@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kobayashi |
Organization
Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
173-8610
Address
30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo
TEL
+81-3-3972-8111
Homepage URL
kobayashi.hiroki@nihon-u.ac.jp
Sponsor or person
Institute
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hatogaya Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon university Itabashi hospital clinical reseach center
Address
30-1 Oyaguchi Kami-chou, Itabashi-ku, Tokyo
Tel
+81-3-3972-8111
med.itabashi.chiken@nihon-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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 15 | 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 | 09 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2030 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comprehensive protein profiling in blood and urine using Olink Explore HT in patients with CKD or at risk for CKD
Annual clinical laboratory data (eGFR, Cr, liver function, HbA1c, blood pressure, lipids, CRP, Na, K, renal injury markers, urinary protein, etc.) and imaging examinations (ABI test, cardiac ultrasound, chest X-ray)
Effects of concomitant medications on renal function decline based on medical records
Associations between multidisciplinary interventions, including nutritional counseling and CKD care guidance, and renal function decline
Information on comorbidities (diabetes mellitus, cardiovascular disease, hypertension, etc.)
Prognostic information (ESKD, cardiovascular events, death)
Baseline information at the time of informed consent (sex, age, medical history, smoking history, body composition, etc.)
Measurement of known biomarkers to evaluate their associations with future renal function decline and cardiovascular events
Genetic factors analyzed using DNA derived from blood cells
RNA and epigenetic markers derived from blood cells
Future omics analyses (proteome, transcriptome, epigenome, etc.) using stored biospecimens
Circulating non-coding RNAs in blood
Management information
Registered date
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067941
