UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059882 |
|---|---|
| Receipt number | R000068479 |
| Scientific Title | A Cross-Sectional Survey to Evaluate the Effectiveness of Regional Medical Collaboration between Primary Care Physicians and Nephrologists on the Management of Chronic Kidney Disease in Japan. |
| Date of disclosure of the study information | 2025/11/26 |
| Last modified on | 2025/11/25 19:53:46 |
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Basic information
Public title
A Cross-Sectional Survey to Evaluate the Effectiveness of Regional Medical Collaboration between Primary Care Physicians and Nephrologists on the Management of Chronic Kidney Disease in Japan.
Acronym
Regional Healthcare Collaboration for Chronic Kidney Disease in Japan
Scientific Title
A Cross-Sectional Survey to Evaluate the Effectiveness of Regional Medical Collaboration between Primary Care Physicians and Nephrologists on the Management of Chronic Kidney Disease in Japan.
Scientific Title:Acronym
A Cross-Sectional Survey to Evaluate the Effectiveness of Regional Medical Collaboration between Primary Care Physicians and Nephrologists on the Management of Chronic Kidney Disease in Japan.
Region
| Japan |
Condition
Condition
Chronic kidney disease(CKD)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective is to compare key clinical practice indicators, such as implementation rates of recommended laboratory tests and guideline awareness, between participating and non-participating primary care physicians.
Basic objectives2
Others
Basic objectives -Others
Web-based questionnaire
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Implementation rate of serum Cr/eGFR tests
2. Implementation rate of urinalysis
3. Awareness of the existence of Clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2024 Evidence-based Clinical Practice Guideline for CKD 2023
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
1. Be a PCP at a clinic in Japan.
2. Be registered on the nationwide M3 platform.
Key exclusion criteria
Self-report nephrology as their primary specialty.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Katsuhito |
| Middle name | |
| Last name | Ihara |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medical Affairs, Medicine Department 1, CDMA Cardio-Renal-Metabolism, Medicine Division
Zip code
141-6017
Address
ThinkPark Tower, 2-1-1 Osaki, Shinagawa-ku Tokyo, 141-6017, Japan
TEL
+81-3-6417-2055
katsuhito.ihara@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Katsuhito |
| Middle name | |
| Last name | Ihara |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medical Affairs, Medicine Department 1, CDMA Cardio-Renal-Metabolism, Medicine Division
Zip code
141-6017
Address
ThinkPark Tower, 2-1-1 Osaki, Shinagawa-ku Tokyo, 141-6017, Japan
TEL
+81-3-6417-2055
Homepage URL
katsuhito.ihara@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
Institutional Review Board,Medical Corporation Ouryokukai Nihonbashi Sakura Clinic
Address
1-9-2 Nihonbashikayabacho, 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
| 2025 | Year | 11 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will collect information from physicians through web-based questionnaires.
The information collected is the information shown in the endpoints.
Management information
Registered date
| 2025 | Year | 11 | Month | 26 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068479
