UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060879 |
|---|---|
| Receipt number | R000069091 |
| Scientific Title | A retrospective 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 | 2026/03/09 |
| Last modified on | 2026/03/09 21:18:16 |
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Basic information
Public title
A retrospective cohort study on predictors of renal function decline in a population at risk for the onset and progression of chronic kidney disease
Acronym
A retrospective 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 retrospective 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 retrospective 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
NO
Objectives
Narrative objectives1
The objective of this study is to identify factors associated with renal function decline (progression of chronic kidney disease [CKD]) among patients with CKD and those at high risk for CKD onset (including individuals with diabetes mellitus, hypertension, and obesity), using routinely collected clinical information and laboratory data obtained in daily clinical practice. In addition, this study aims to describe the utilization rates and prescribing patterns of renoprotective agents, such as SGLT2 inhibitors and finerenone, including treatment initiation, continuation, discontinuation, and combination therapy, and to examine the clinical factors associated with these patterns.
Basic objectives2
Others
Basic objectives -Others
Based on existing data routinely obtained in real-world clinical practice, this study aims to clarify factors associated with the risk of CKD progression, thereby contributing to early risk stratification and optimization of target populations for intervention. Furthermore, by visualizing real-world patterns of use of renoprotective medications, such as SGLT2 inhibitors and finerenone, and the factors influencing their prescription, this study seeks to identify gaps between guideline recommendations and actual clinical practice, thereby providing implementation-oriented evidence to promote appropriate use of these agents and to suppress CKD progression and cardiovascular events.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Renal function decline will be evaluated based on the estimated glomerular filtration rate (eGFR) at baseline and the subsequent eGFR slope (annual rate of decline in eGFR). Associations between renal function decline and patient background characteristics, comorbidities, blood pressure, laboratory data, concomitant medications, and existing clinical items, including nutritional counseling, will be examined.
Key secondary outcomes
Renal function decline (CKD progression):eGFR at baseline; subsequent eGFR slope (annual rate of decline in eGFR); associations with patient background characteristics, comorbidities, blood pressure, laboratory data, concomitant medications, and existing clinical items, including nutritional counseling
Use of renoprotective medications: including SGLT2 inhibitors, finerenone, GLP-1 receptor agonists, antihypertensive medications; prescription rates, initiation, continuation, discontinuation, and combination patterns
Cardiovascular events and all-cause mortality
Annual clinical laboratory data: eGFR, Cr, liver function tests, HbA1c, blood pressure, lipid profile, CRP, Na, K, markers of kidney injury, urinary protein
Imaging examinations: ABI, echocardiography, chest X-ray
Treating physician information
Concomitant medications based on medical records: Use of SGLT2 inhibitors, RAS inhibitors, finerenone, GLP-1 receptor agonists, ACE inhibitors/ARBs, and diuretics, and their impact on renal function decline
Associations between renal function decline and multidisciplinary collaboration, including nutritional counseling and chronic kidney disease self-management education
Comorbidity information: Diabetes mellitus, cardiovascular disease, hypertension, and other comorbidities
Prognostic information: ESKD, cardiovascular events, mortality
Baseline information at the time of informed consent: Sex, age, medical history, smoking history, body size, and other relevant baseline characteristics
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
Patients who visited the Department of Nephrology, Hypertension, and Endocrinology at Nihon University Itabashi Hospital and were diagnosed with chronic kidney disease, or those with diabetes, hypertension, or obesity who were considered to be at high risk of developing chronic kidney disease in the future, from January 1, 2014 to February 1, 2030.
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
1500
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
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
| 2026 | Year | 03 | Month | 09 | 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
| 2026 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2031 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Renal function decline (CKD progression):eGFR at baseline; subsequent eGFR slope (annual rate of decline in eGFR); associations with patient background characteristics, comorbidities, blood pressure, laboratory data, concomitant medications, and existing clinical items, including nutritional counseling
Use of renoprotective medications: including SGLT2 inhibitors, finerenone, GLP-1 receptor agonists, antihypertensive medications; prescription rates, initiation, continuation, discontinuation, and combination patterns
Cardiovascular events and all-cause mortality
Annual clinical laboratory data: eGFR, Cr, liver function tests, HbA1c, blood pressure, lipid profile, CRP, Na, K, markers of kidney injury, urinary protein
Imaging examinations: ABI, echocardiography, chest X-ray
Treating physician information
Concomitant medications based on medical records: Use of SGLT2 inhibitors, RAS inhibitors, finerenone, GLP-1 receptor agonists, ACE inhibitors/ARBs, and diuretics, and their impact on renal function decline
Associations between renal function decline and multidisciplinary collaboration, including nutritional counseling and chronic kidney disease self-management education
Comorbidity information: Diabetes mellitus, cardiovascular disease, hypertension, and other comorbidities
Prognostic information: ESKD, cardiovascular events, mortality
Baseline information at the time of informed consent: Sex, age, medical history, smoking history, body size, and other relevant baseline characteristics
Management information
Registered date
| 2026 | Year | 03 | Month | 09 | Day |
Last modified on
| 2026 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069091
