UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061950 |
|---|---|
| Receipt number | R000070890 |
| Scientific Title | Improving CKD Diagnosis and Treatment Rates Through Support Programs in Primary Care Settings. |
| Date of disclosure of the study information | 2026/06/18 |
| Last modified on | 2026/06/17 20:53:43 |
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Basic information
Public title
Improving CKD Diagnosis and Treatment Rates Through Support Programs in Primary Care Settings: A Scientific Approach to Investigating a Multi-Channel Support Program to Improve CKD Diagnosis and Management in Primary Care. (Phase 1)
Acronym
Improving CKD Diagnosis and Treatment Rates Through Support Programs in Primary Care Settings.
Scientific Title
Improving CKD Diagnosis and Treatment Rates Through Support Programs in Primary Care Settings.
Scientific Title:Acronym
CKD Support Program Implementation Study
Region
| Japan |
Condition
Condition
Chronic kidney disease (CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the level of understanding regarding CKD among primary care physicians, including disease knowledge, diagnostic definitions, diagnostic methods, and pharmacotherapy interventions through a questionnaire survey.
Basic objectives2
Others
Basic objectives -Others
To evaluate changes in the prescription rate of SGLT2 inhibitors among primary care physicians (PCPs).
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Level of knowledge and awareness
-Recognition of CKD diagnostic definitions
-Recognition of CKD referral criteria
-Awareness of CKD risk factors
-Perception of useful indicators/tests for recognizing CKD
-Recognition of the indications for SGLT2 inhibitors and Mineralocorticoid receptor antagonists (MRAs) in CKD and diabetic kidney disease
Barriers and needs
-Perceived barriers to performing blood tests for CKD diagnosis
-Perceived barriers to performing urine tests for CKD diagnosis
-Information and support needs as a primary care physician regarding CKD diagnosis and treatment
Key secondary outcomes
Screening frequency for at-risk patients:
-Frequency of blood tests (serum creatinine, eGFR) for patients with CKD risk factors
-Frequency of urine tests (urine albumin-to-creatinine ratio, urine protein-to-creatinine ratio, qualitative proteinuria) for patients with CKD risk factors
-Monitoring frequency for diagnosed patients
-Frequency of blood tests for patients recognized as having CKD
Treatment status
-Utilization of specific medications for CKD patients with comorbid diabetes mellitus or albuminuria/proteinuria
Status of guideline engagement
-Awareness of the "Clinical practice guidebook for diagnosis and treatment of chronic kidney disease 2024" and "Evidence-based clinical practice guideline for CKD 2023"
-Possession status of the "Clinical practice guidebook for diagnosis and treatment of chronic kidney disease 2024"
-Reasons for non-possession of the "Clinical practice guidebook for diagnosis and treatment of chronic kidney disease 2024"
Clinical practice and attitudes
-Self-confidence in CKD management
-Recognition of the necessity to evaluate renal function in at-risk patients
-Disease naming conventions used for registration
-Implementation status of specific checks/confirmations for patients diagnosed with CKD
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
-PCPs practicing at a clinic in Japan.
-PCPs registered on the nationwide M3 platform.
-PCPs having opportunities to diagnose and treat patients with CKD.
Key exclusion criteria
PCPs self-reporting their primary specialty in any fields other than the designated internal medicine subspecialties, which include general internal medicine, cardiology, gastroenterology, respiratory medicine, diabetes/endocrinology and metabolism, rheumatology/collagen disease, and allergy.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yoneda |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Clinical Development and Medical Affairs
Zip code
141-6017
Address
ThinkPark Tower, 2-1-1 Osaki, Shinagawa-ku, Tokyo, Japan
TEL
03-6417-2200
kazuhiro.yoneda@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Asanuma |
Organization
Mebix, Inc.
Division name
Research Promotion Division
Zip code
105-0001
Address
10th Floor, Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-4362-4504
Homepage URL
Implementation_Study_Support@mebix.co.jp
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
Ethics Committee of Nihonbashi Sakura Clinic, Ouryokukai Medical Corporation
Address
5th Floor, Inamura Building, 1-9-2 Nihonbashi Kayabacho, Chuo-ku, Tokyo
Tel
03-6661-9061
c-irb_ug@neues.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 | 06 | Month | 18 | 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 | 08 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an implementation science study (Phase 1) intended to inform the development and evaluation of a multichannel support program to improve chronic kidney disease diagnosis and management in primary care in Japan. An online questionnaire survey of primary care physicians working in clinics in Japan will be conducted to assess their knowledge of chronic kidney disease, current practices in diagnosis, screening, and treatment, and the barriers and support needs associated with routine clinical care.
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070890
