UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061789 |
|---|---|
| Receipt number | R000070710 |
| Scientific Title | Impact of add-on finerenone therapy on the 2-year rate of renal function decline and albuminuria in patients with diabetic kidney disease receiving SGLT2 inhibitor treatment: A retrospective observational study |
| Date of disclosure of the study information | 2026/06/05 |
| Last modified on | 2026/06/03 17:59:50 |
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Basic information
Public title
Long-term retrospective effects of add-on finerenone therapy in patients with diabetic kidney disease
Acronym
FINER-DKD
Scientific Title
Impact of add-on finerenone therapy on the 2-year rate of renal function decline and albuminuria in patients with diabetic kidney disease receiving SGLT2 inhibitor treatment: A retrospective observational study
Scientific Title:Acronym
FINER-DKD
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus with diabetic kidney disease (DKD)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the 2-year eGFR slope following add-on finerenone therapy in patients with type 2 diabetes mellitus and diabetic kidney disease (DKD) receiving SGLT2 inhibitor treatment, and to assess its impact on the rate of renal function decline. Changes in albuminuria and safety outcomes will also be evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eGFR slope (mL/min/1.73 m2/year) during the 2 years following initiation of finerenone therapy
Key secondary outcomes
Comparison of eGFR slope before and after finerenone initiation
Annual eGFR slope during years 0-1 and 1-2 after finerenone initiation
Longitudinal changes in urinary albumin-to-creatinine ratio (UACR)
Proportion of UACR responders (30% or greater reduction from baseline)
Renal outcomes according to baseline eGFR categories
Safety outcomes, including changes in serum potassium levels, incidence of hyperkalemia, acute decline in eGFR, and discontinuation rate of finerenone
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with type 2 diabetes mellitus
Patients with diabetic kidney disease (DKD)
Patients newly initiated on finerenone while receiving SGLT2 inhibitor therapy
Availability of eGFR data for at least 12 months before finerenone initiation
Availability of follow-up data for at least 24 months after finerenone initiation
Key exclusion criteria
Patients receiving dialysis therapy
Patients with a history of kidney transplantation
Patients with acute kidney injury
Patients with missing data required for analysis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Kawaguchi |
Organization
Minami Osaka Hospital
Division name
internal medicine
Zip code
559-0012
Address
1-18-18 Higashi-Kagaya, Suminoe-ku, Osaka-shi, Osaka 559-0012, Japan
TEL
0666850221
y.kawaguchi@minamiosaka.com
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Kawaguchi |
Organization
Minami Osaka hospital
Division name
internal medicine
Zip code
559-0012
Address
1-18-18 Higashi-Kagaya, Suminoe-ku, Osaka-shi, Osaka 559-0012, Japan
TEL
0666850221
Homepage URL
y.kawaguchi@minamiosaka.com
Sponsor or person
Institute
Minami Osaka hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Minami Osaka hospital
Address
1-18-18 Higashi-Kagaya, Suminoe-ku, Osaka-shi, Osaka 559-0012, Japan
Tel
0666850221
y.kawaguchi@minamiosaka.com
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 | 05 | 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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center retrospective observational study. Patients with type 2 diabetes mellitus and diabetic kidney disease (DKD) who were newly initiated on finerenone while receiving SGLT2 inhibitor therapy at Minami Osaka Hospital between April 1, 2023 and April 30, 2024 will be included. For each patient, the date of finerenone initiation will be defined as the index date. The observation period will consist of 12 months before and 24 months after the index date. Clinical data obtained from electronic medical records will be used to evaluate eGFR slope, changes in albuminuria, and safety outcomes following add-on finerenone therapy.
Management information
Registered date
| 2026 | Year | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070710
