UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038835 |
|---|---|
| Receipt number | R000044289 |
| Scientific Title | A prospective observational study in type 2 diabetic patients showing reduced eGFR without albuminuria |
| Date of disclosure of the study information | 2019/12/11 |
| Last modified on | 2024/01/09 11:58:26 |
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Basic information
Public title
A prospective observational study in type 2 diabetic patients showing reduced eGFR without albuminuria
Acronym
A prospective observational study in type 2 diabetic patients showing reduced eGFR without albuminuria
Scientific Title
A prospective observational study in type 2 diabetic patients showing reduced eGFR without albuminuria
Scientific Title:Acronym
A prospective observational study in type 2 diabetic patients showing reduced eGFR without albuminuria
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the prognosis in Japanese patients with type 2 diabetes showing reduced eGFR without albuminuria.
Basic objectives2
Others
Basic objectives -Others
Changes in eGFR, end-stage kidney disease, Incidence of cardiovascular disease, all-cause mortality for 4 years observation are investigated
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in eGFR, end-stage kidney disease, cardiovascular disease, all-cause mortality for 4 years observation
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patient with type 2 diabetes already evaluated eGFR, uACR and diabetic macroangiopathies
Key exclusion criteria
none
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052, Japan
TEL
03-3673-1229
ito@edogawa.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052, Japan
TEL
03-3673-1229
Homepage URL
ito@edogawa.or.jp
Sponsor or person
Institute
Edogawa Hospital
Department of Diabetes, Metabolism and Kidney Disease
Institute
Department
Personal name
Funding Source
Organization
Edogawa Hospital
Department of Diabetes, Metabolism and Kidney Disease
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Edogawa Hospital
Address
2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052, Japan
Tel
03-3673-1229
ito@edogawa.or.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
| 2019 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10157-020-01935-3
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10157-020-01935-3
Number of participants that the trial has enrolled
675
Results
In the group with a reduced eGFR, the eGFR value did not significantly change in the subjects without albuminuria , whereas it decreased continuously in those with albuminuria. The incidence of cardiovascular events was significantly higher in the subjects with albuminuria than those without albuminuria in the group with a reduced eGFR. Cardiovascular events were significantly more frequent in the group with a reduced eGFR than in those with a preserved eGFR in both subjects with and without albuminuria.
Results date posted
| 2024 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
675 patients with type 2 diabetes
Participant flow
675 patients with type 2 diabetes
Adverse events
N/A
Outcome measures
Renal and cardiovascular events
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
n/a
Management information
Registered date
| 2019 | Year | 12 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044289
| Research Plan | |
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| Registered date | File name |
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