UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054821 |
|---|---|
| Receipt number | R000062642 |
| Scientific Title | Efficacy and Safety of Finerenone in Type 2 Diabetes Individuals with Diabetic Kidney Disease |
| Date of disclosure of the study information | 2024/08/10 |
| Last modified on | 2024/06/29 10:56:23 |
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Basic information
Public title
Efficacy and Safety of Finerenone in Type 2 Diabetes Individuals with Diabetic Kidney Disease
Acronym
Efficacy and Safety of Finerenone in Type 2 Diabetes Individuals with Diabetic Kidney Disease
Scientific Title
Efficacy and Safety of Finerenone in Type 2 Diabetes Individuals with Diabetic Kidney Disease
Scientific Title:Acronym
Efficacy and Safety of Finerenone in Type 2 Diabetes Individuals with Diabetic Kidney Disease
Region
| Japan |
Condition
Condition
Type 2 Diabetes Individuals with Diabetic Kidney Disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessing the Efficacy and Safety of Finerenone in Outpatient Type 2 Diabetes Individuals with Diabetic Kidney Disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy: Change in Urine Albumin-to-Creatinine Ratio (UACR) from baseline
Safety: Change in Serum Potassium Levels from baseline
Key secondary outcomes
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
Type 2 diabetes outpatients with diabetic kidney disease who required treatment with Finerenone as indicated from April 1, 2023, to August 31, 2024.
Key exclusion criteria
No particular details
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Kawaguchi |
Organization
Minami Osaka Hospital
Division name
Department of Internal Medicine
Zip code
5590012
Address
1-18-18, Higashikagaya, Suminoe-ku, 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
Department of Internal Medicine
Zip code
5590012
Address
1-18-18, Higashikagaya, Suminoe-ku, 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
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
Minami Osaka Hospital
Address
1-18-18, Higashikagaya, Suminoe-ku, 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
| 2024 | Year | 08 | Month | 10 | 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
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062642
