UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063230 |
|---|---|
| Receipt number | R000072372 |
| Scientific Title | Effectiveness and safety of continuous low-dose (10 mg/day) finerenone administration in patients with type 2 diabetes and chronic kidney disease |
| Date of disclosure of the study information | 2026/10/09 |
| Last modified on | 2026/10/09 15:12:58 |
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Basic information
Public title
Effectiveness and safety of continuous low-dose (10 mg/day) finerenone administration in patients with type 2 diabetes and chronic kidney disease
Acronym
Effectiveness and safety of continuous low-dose (10 mg/day) finerenone administration in patients with type 2 diabetes and chronic kidney disease
Scientific Title
Effectiveness and safety of continuous low-dose (10 mg/day) finerenone administration in patients with type 2 diabetes and chronic kidney disease
Scientific Title:Acronym
Effectiveness and safety of continuous low-dose (10 mg/day) finerenone administration in patients with type 2 diabetes and chronic kidney disease
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes and chronic kidney disease.
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical effectiveness (changes in urinary albumin-to-creatinine ratio and estimated glomerular filtration rate) and safety (changes in serum potassium levels) of continuous low-dose (10 mg/day) finerenone therapy over 6 months in patients with type 2 diabetes and chronic kidney disease in a real-world clinical setting. Furthermore, this study aims to explore baseline objective indicators for safe treatment continuation by identifying factors associated with early serum potassium elevation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in urinary albumin-to-creatinine ratio (uACR) from baseline at 6 months of administration
Key secondary outcomes
1.Time-course changes in estimated glomerular filtration rate (eGFR) and serum potassium levels up to 6 months after finerenone initiation. 2. Identification of factors associated with the change in serum potassium levels at 1 month of administration, as well as factors associated with maintaining serum potassium levels at <= 4.8 mEq/L.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with type 2 diabetes and chronic kidney disease. 2. Patients who initiated finerenone at 10 mg/day between August 2023 and December 2025 at our outpatient clinic. 3. Patients who continuously received finerenone at 10 mg/day for 6 months based on the clinical judgment of their attending physicians.
Key exclusion criteria
1. Patients whose finerenone dose was increased to 20 mg/day within 6 months. 2. Patients with an observation period of less than 6 months (e.g., due to death, transfer, or lost to follow-up). 3. Patients who discontinued finerenone due to adverse events or other clinical reasons within 6 months.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-Ku, Tokyo
TEL
+81-3-3673-1221
ito@edogawa.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-Ku, Tokyo
TEL
+81-3-3673-1221
Homepage URL
ito@edogawa.or.jp
Sponsor or person
Institute
Edogawa Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics Committee of Edogawa Hospital
Address
2-24-18, Higashikoiwa, Edogawa-Ku, Tokyo
Tel
+81-3-3673-1221
ito@edogawa.or.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 | 10 | 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
60
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
Completed
Date of protocol fixation
| 2026 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2026 | Year | 10 | Month | 09 | Day |
Last modified on
| 2026 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072372
