UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057999 |
|---|---|
| Receipt number | R000066300 |
| Scientific Title | Retrospective Observational Study on the Effectiveness and Safety of Finerenone in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease |
| Date of disclosure of the study information | 2025/07/30 |
| Last modified on | 2026/05/29 11:24:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of Finerenone Treatment Effects and Safety
Acronym
Finerenone Effectiveness and Safety Study
Scientific Title
Retrospective Observational Study on the Effectiveness and Safety of Finerenone in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease
Scientific Title:Acronym
Finerenone Retrospective Observational Study in T2DM with CKD
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effectiveness and safety of finerenone in patients with type 2 diabetes mellitus and chronic kidney disease using real-world clinical data, as well as to investigate the impact of concomitant use of SGLT2 inhibitors and ACE inhibitors or ARBs on the effects of finerenone.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is the change in estimated glomerular filtration rate (eGFR) at 3 months and 6 months after the initiation of treatment.
Key secondary outcomes
Secondary outcomes include changes in urinary albumin-to-creatinine ratio, serum potassium levels, urinary sodium excretion, and blood pressure after treatment initiation.
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 treated at Meitetsu Hospital
Aged 18 years or older
Diagnosed with type 2 diabetes and chronic kidney disease and initiated on finerenone
Able to be followed for at least 3 months
Opt-out consent has been appropriately obtained
Key exclusion criteria
Patients with end-stage renal disease (on dialysis or eGFR <15 mL/min/1.73m)
Patients who discontinued finerenone within one month after initiation
Patients deemed inappropriate for inclusion by the attending physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Saori |
| Middle name | |
| Last name | Inoue |
Organization
Meitetsu Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
451-0052
Address
2-26-11 Sako, Nishi-ku, Nagoya, Aichi, Japan
TEL
+81-570-023-100
saori.inoue@meitetsu-hpt.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Inoue |
Organization
Meitetsu Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
4510052
Address
2-26-11 Sako, Nishi-ku, Nagoya, Aichi, Japan
TEL
+81-570-023-100
Homepage URL
saori.inoue@meitetsu-hpt.jp
Sponsor or person
Institute
Meitetsu 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
Institutional Review Board, Meitetsu Hospital
Address
2-26-11 Sako, Nishi-ku, Nagoya, Aichi, Japan
Tel
+81-570-023-100
jimubu_uketuke@meitetsu-hpt.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
名鉄病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 30 | Day |
Related information
URL releasing protocol
https://link.springer.com/epdf/10.1007/s13340-025-00866-2?sharing_token=nQEGZ8HX3cvl8x1DO6pHove4RwlQ
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/epdf/10.1007/s13340-025-00866-2?sharing_token=nQEGZ8HX3cvl8x1DO6pHove4RwlQ
Number of participants that the trial has enrolled
96
Results
A total of 83 patients were analyzed. UACR significantly decreased in both the ACEi/ARB and non-ACEi/ARB groups. The reduction was greater in the ACEi/ARB group (p=0.006). eGFR significantly decreased and serum potassium slightly increased only in the ACEi/ARB group.
Results date posted
| 2026 | Year | 05 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 83 patients with diabetes and chronic kidney disease who initiated finerenone therapy. Fifty-two patients received concomitant ACEi/ARB therapy and 31 did not. The median age was 77 years in both groups, and 71% were male. Baseline HbA1c, UACR, and serum potassium levels were comparable between groups, whereas baseline eGFR was significantly lower in the ACEi/ARB group.
Participant flow
Ninety-six patients who initiated finerenone between June 2022 and March 2025 were screened. Of these, 83 patients with at least 3 months of follow-up were included in the analysis. Fifty-two patients were classified into the ACEi/ARB group and 31 into the non-ACEi/ARB group. During follow-up, 11 patients discontinued treatment because of adverse events.
Adverse events
Treatment discontinuation due to adverse events occurred in 11 patients, including hyperkalemia (n=7), loss of appetite (n=2), renal dysfunction (n=1), and switching to esaxerenone because of elevated blood pressure (n=1). The maximum serum potassium concentration observed in patients with hyperkalemia was 6.8 mmol/L.
Outcome measures
The primary outcome was the change in urinary albumin-to-creatinine ratio (UACR) from baseline to 3 months after initiation of finerenone. Secondary outcomes included changes in estimated glomerular filtration rate (eGFR), serum potassium levels, and the occurrence of adverse events
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with type 2 diabetes and chronic kidney disease who were treated with finerenone during a 37-month period from June 1, 2022, to March 31, 2025, while receiving various pharmacological therapies.
Management information
Registered date
| 2025 | Year | 05 | Month | 28 | Day |
Last modified on
| 2026 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066300
