UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055007 |
|---|---|
| Receipt number | R000062749 |
| Scientific Title | Association between Fetuin-A Fragment and Diabetic Kidney Disease in the Japanese Population |
| Date of disclosure of the study information | 2024/07/18 |
| Last modified on | 2024/07/18 10:03:23 |
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Basic information
Public title
Association between Fetuin-A Fragment and Diabetic Kidney Disease in the Japanese Population
Acronym
Association between Fetuin-A Fragment and Diabetic Kidney Disease in the Japanese Population
Scientific Title
Association between Fetuin-A Fragment and Diabetic Kidney Disease in the Japanese Population
Scientific Title:Acronym
Association between Fetuin-A Fragment and Diabetic Kidney Disease in the Japanese Population
Region
| Japan |
Condition
Condition
Diabetic Kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the association between Fetuin-A fragment and the development of diabetes-related kidney disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fetuin-A Fragment
eGFR
Albumin
Creatinine
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years and older at the time of obtaining consent.
Patients who, prior to the initiation of the observational study, received a thorough explanation from the principal investigator or the responsible physician (referred to as "attending physician") about the purpose, content, and anticipated secondary effects of the study, and who, after a comprehensive understanding, voluntarily agreed to participate in the observational study and provided written consent for participation.
Patients for whom written consent for participation in the study has been obtained personally.
Key exclusion criteria
Patients diagnosed with dementia.
Patients with Type 1 diabetes, pregnant individuals, malignancies, and those suffering from chronic/acute infections.
Patients with acute conditions requiring emergency intervention.
Patients who have shown primary or secondary kidney disorders or symptoms prior to diabetes diagnosis.
Patients diagnosed with alcohol or substance abuse within 3 months before signing the consent form.
Patients whom the attending physician has deemed inappropriate for participation in the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | None |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism, and Nephrology
Zip code
133-0052
Address
2-24-18 Higashi-Koiwa, Edogawa-ku, Tokyo ,Japan
TEL
03-3673-4892
ito@edogawa.or.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | None |
| Last name | Maruta |
Organization
Premedica Inc.
Division name
Overseas Sales & Marketing Division
Zip code
105-0011
Address
Terada Bldg. 5F, 2-3-3, Shibakoen, Minato-ku, Tokyo
TEL
03-5776-1105
Homepage URL
tomohiro.maruta@premedica.co.jp
Sponsor or person
Institute
Edogawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Premedica Inc.
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
Premedica Inc.
Address
Terada Bldg. 5F, 2-3-3, Shibakoen, Minato-ku, Tokyo
Tel
03-5776-1105
tomohiro.maruta@premedica.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
| 2024 | Year | 07 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | 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 | 07 | Month | 18 | Day |
Last modified on
| 2024 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062749
