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 | 2025/05/28 14:35:33 |
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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
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
96
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
No longer recruiting
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 March 1, 2022, to March 31, 2025, while receiving various pharmacological therapies.
Management information
Registered date
| 2025 | Year | 05 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066300
