UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060242 |
|---|---|
| Receipt number | R000068891 |
| Scientific Title | Effects of Additional Spironolactone on Persistent Proteinuria After SGLT2 Inhibitor Therapy in Patients with Diabetic Kidney Disease |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2025/12/31 09:56:23 |
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Basic information
Public title
Effects of Additional Spironolactone on Persistent Proteinuria After SGLT2 Inhibitor Therapy in Patients with Diabetic Kidney Disease
Acronym
Spironolactone Improved Kidney Function after SGLT2i-Therapy
Scientific Title
Effects of Additional Spironolactone on Persistent Proteinuria After SGLT2 Inhibitor Therapy in Patients with Diabetic Kidney Disease
Scientific Title:Acronym
Effects of Additional Spironolactone on Persistent Proteinuria After SGLT2 Inhibitor Therapy in Patients with Diabetic Kidney Disease
Region
| Japan |
Condition
Condition
Type-2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
spironolactone therapy-induced changes in urinary protein-to-creatinine ratio (UPCR) levels
Basic objectives2
Others
Basic objectives -Others
the spironolactone treatment-induced changes in the annual rate of eGFR decline
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint was spironolactone therapy-induced changes in urinary protein-to-creatinine ratio (UPCR) levels.
Key secondary outcomes
The secondary outcome was the spironolactone treatment-induced changes in the annual rate of eGFR decline.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
stable adult T2DM patients demonstrated persistent proteinuria (UPCR; A2 to A3; >0.15 g/gCre) despite more than 6 months of SGLT2i therapy (dapagliflozin; 10 mg/day) at the outpatient's department in Jinnouchi Hospital between January 2019 and July 2022 and initiated additional spironolactone therapy (initial dose; 12.5 mg/day). Patients were included if levels of proteinuria and eGFR measurements were performed both before and after the initiation of spironolactone and follow-up periods were 12 months.
Key exclusion criteria
Patients with hyperkalemia (K>5.5), cancer, severe infection, recent cardiovascular events, heart failure (New York Heart Association class III or higher), advanced chronic kidney disease (eGFR<15 mL/min/1.73 m2), advanced hepatic diseases, or concomitant use of eplerenone were excluded.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Sugiyama |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
862-0976
Address
6-2-3 Kuhonji Chuo-ku, Kumamoto City, Kumamoto Japan
TEL
0963630011
seigosugiyama@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Sugiyama |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
862-0976
Address
6-2-3 Kuhonji Chuo-ku, Kumamoto City, Kumamoto Japan
TEL
0963630011
Homepage URL
seigosugiyama@jinnouchi.or.jp
Sponsor or person
Institute
Jinnouchi Hospital
Institute
Department
Personal name
Seigo Sugiyama
Funding Source
Organization
Jinnouchi Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Jinnouchi Hospital
Address
6-2-3 Kuhonji Chuo-ku, Kumamoto City, Kumamoto Japan
Tel
0963630011
seigosugiyama@jinnouchi.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
熊本県
Institutions
Institutions
陣内病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
29
Results
Spironolactone significantly decreased proteinuria in patients with persistent proteinuria after SGLT2i therapy.
Results date posted
| 2025 | Year | 12 | Month | 31 | Day |
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
| 2023 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 01 | Day |
Other
Other related information
Data analyses are on going.
Management information
Registered date
| 2025 | Year | 12 | Month | 31 | Day |
Last modified on
| 2025 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068891
