UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052393 |
|---|---|
| Receipt number | R000059811 |
| Scientific Title | A study to clarify the diagnostic status of Chronic Kidney Disease using a real-world database in Japan |
| Date of disclosure of the study information | 2023/10/03 |
| Last modified on | 2024/07/02 14:14:22 |
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Basic information
Public title
A study to clarify the diagnostic status of Chronic Kidney Disease using a real-world database in Japan
Acronym
CHECK-CKD
Scientific Title
A study to clarify the diagnostic status of Chronic Kidney Disease using a real-world database in Japan
Scientific Title:Acronym
CHECK-CKD
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the annual diagnosis rate of CKD and its diagnostic status in Japan using medical claims database.
Basic objectives2
Others
Basic objectives -Others
Understanding the annual diagnosis rate of CKD and factors associated with CKD diagnosis
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The annual diagnosis rate of CKD
Key secondary outcomes
Patients background by presence/absence of the diagnosis of CKD
Patients background by presence/absence of medical institution visits
The rate of Cardiorenal events by presence/absence of the diagnosis of CKD
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study patients should fulfil any of the following criteria
eGFR Under60mL per min per 1.73m2
urine dipstick test Over 1Plus
Key exclusion criteria
None
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | MASARU |
| Middle name | |
| Last name | KAWASHIMA |
Organization
ONO PHARMACEUTICAL CO., LTD
Division name
Medical Affaires
Zip code
541-8564
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka, Japan
TEL
06-6263-5670
m.kawashima@ono-pharma.com
Public contact
Name of contact person
| 1st name | Keigo |
| Middle name | |
| Last name | Kanafuri |
Organization
ONO PHARMACEUTICAL CO., LTD
Division name
Medical Affaires
Zip code
103-0023
Address
9-11, Nihonbashi-Honcho 4-chome, Chuo-ku, Tokyo, Japan
TEL
03-5640-3701
Homepage URL
kanafuri@ono-pharma.com
Sponsor or person
Institute
ONO PHARMACEUTICAL CO., LTD
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL 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
Ono Pharmaceutical Co.,ltd.
Address
8-2,Kyuutaromachi1-chome,Chuo-ku, osaka-shi,Osaka
Tel
06-6263-5670
n.nishiwaki@ono-pharma.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
| 2023 | Year | 10 | Month | 03 | 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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses the administrative claims database. The data is anonymized and no identifiable personal information is included in the database. Therefore, this study does not require approval by IRB.
Management information
Registered date
| 2023 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059811
