UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062116 |
|---|---|
| Receipt number | R000071056 |
| Scientific Title | Estimating Trial-Eligible CKD Populations for Major Kidney Outcome Trials and SGLT2 Inhibitor Benefits in Japan: A Descriptive Analysis and Projection of SGLT2 Inhibitor Prescription and Potential Reductions in ESKD and Cardiovascular Events |
| Date of disclosure of the study information | 2026/07/02 |
| Last modified on | 2026/07/02 10:25:28 |
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Basic information
Public title
Estimating Trial-Eligible CKD Populations for Major Kidney Outcome Trials and SGLT2 Inhibitor Benefits in Japan: A Descriptive Analysis and Projection of SGLT2 Inhibitor Prescription and Potential Reductions in ESKD and Cardiovascular Events
Acronym
Estimated Trial-Eligible CKD Patients and SGLT2i Benefits in Japan: A Descriptive and Simulation Study
Scientific Title
Estimating Trial-Eligible CKD Populations for Major Kidney Outcome Trials and SGLT2 Inhibitor Benefits in Japan: A Descriptive Analysis and Projection of SGLT2 Inhibitor Prescription and Potential Reductions in ESKD and Cardiovascular Events
Scientific Title:Acronym
Estimated Trial-Eligible CKD Patients and SGLT2i Benefits in Japan: A Descriptive and Simulation Study
Region
| Japan |
Condition
Condition
Chronic Kidney Disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the number of CKD patients across Japan meeting the eligibility criteria of major sodium-glucose cotransporter 2 inhibitor (SGLT2i) clinical trials for kidney outcome, and the number of those prescribed SGLT2i.
Basic objectives2
Others
Basic objectives -Others
To estimate the number of CKD patients across Japan meeting the eligibility criteria of major sodium-glucose cotransporter 2 inhibitor (SGLT2i) clinical trials for kidney outcome, and the number of those prescribed SGLT2i.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Estimated number of CKD patients across Japan who meet the eligibility criteria of each major clinical trial of SGLT2i for kidney outcome*
2.Estimated number of patients prescribed SGLT2i and the prescription rate among CKD patients across Japan who meet the eligibility criteria of each major clinical trial of SGLT2i for kidney outcome*
* Major clinical trial of SGLT2i for kidney outcome: EMPA-KIDNEY, DAPA-CKD, and CREDENCE
Key secondary outcomes
<Secondary outcomes>
1.Estimated number of ESKD-projected patients across Japan among patients who meet the eligibility criteria of each major clinical trial of SGLT2i for kidney outcome*
2.Estimated hypothetical reduction in the number of ESKD patients across Japan at the assumed SGLT2i prescription rate, among patients who meet the eligibility criteria of each major clinical trial of SGLT2i for kidney outcome*
3.Estimated ESKD-free life expectancy and proportion of life spent in ESKD-free across Japan at the assumed SGLT2i prescription rate, among patients who meet the eligibility criteria of each major clinical trial of SGLT2i for kidney outcome*
<Exploratory outcomes>
1.Estimated annual number of CV events across Japan among patients who meet the eligibility criteria of each major clinical trial of SGLT2i for kidney outcome*, extrapolated from trial-specific incidence rates for each trial
2.Estimated annual hypothetical reduction in the number of CV events across Japan at the assumed SGLT2i prescription rate, among patients who meet the eligibility criteria of each major clinical trial of SGLT2i for kidney outcome*
3.Factors associated with SGLT2i prescription among patients who meet the eligibility criteria of each major clinical trial of SGLT2i for kidney outcome*
* Major clinical trial of SGLT2i for kidney outcome: EMPA-KIDNEY, DAPA-CKD, and CREDENCE
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<For total population>
1.Have at least one instance between January 1 and December 31, 2024, in which both estimated glomerular filtration rate (eGFR) and urinary protein test results are recorded on the same day.
2.Have at least three eGFR measurements, including one on the index date during baseline period, and have the earliest eGFR measurement and the index date separated by at least 2 years.
3.Have been continuously enrolled in the JMDC database throughout the 3-year baseline period.
Key exclusion criteria
<For total population>
No exclusion criteria were defined.
Target sample size
540000
Research contact person
Name of lead principal investigator
| 1st name | Sota |
| Middle name | |
| Last name | Kato |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medicine Division
Zip code
141-6017
Address
ThinkPark Tower 2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
080-2432-0944
sota.kato@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Sota |
| Middle name | |
| Last name | Kato |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medicine Division
Zip code
141-6017
Address
ThinkPark Tower 2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
080-2432-0944
Homepage URL
sota.kato@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
RIHDS Ethical Review Board
Address
12th floor, Sumitomo Shiba Daimon Building 2-5-5 Shiba Daimon, Minato-ku, Tokyo, Japan
Tel
03-5733-5010
rihds@jmdc.co.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 02 | 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 | 06 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 29 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 29 | Day |
Date trial data considered complete
| 2026 | Year | 06 | Month | 29 | Day |
Date analysis concluded
| 2026 | Year | 11 | Month | 30 | Day |
Other
Other related information
This study is an observational and non-interventional study utilizing the existing JMDC database. The data is anonymized and no identifiable personal information is included in the database. Therefore, this study does not require informed consent from the patients.
Management information
Registered date
| 2026 | Year | 07 | Month | 02 | Day |
Last modified on
| 2026 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071056
