UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047632 |
|---|---|
| Receipt number | R000054314 |
| Scientific Title | Influence of anemia for cardiovascular and renal events in patients with type 2 diabetes: a prospective observational study |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2024/01/09 13:51:58 |
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Basic information
Public title
Influence of anemia for cardiovascular and renal events in patients with type 2 diabetes: a prospective observational study
Acronym
Influence of anemia for cardiovascular and renal events in patients with type 2 diabetes: a prospective observational study
Scientific Title
Influence of anemia for cardiovascular and renal events in patients with type 2 diabetes: a prospective observational study
Scientific Title:Acronym
Influence of anemia for cardiovascular and renal events in patients with type 2 diabetes: a prospective observational study
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Incidence of cardiovascular and renal events is investigated in patients with type 2 diabetes who were classified according to degree of anemia and CKD by a prospective observational study.
Basic objectives2
Others
Basic objectives -Others
To determine the incidence of cardiovascular and renal events
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Renal events (ESKD or decline in eGFR by 30% or more from the start of observation).
Key secondary outcomes
Cardiovascular events (cardiovascular death, nonfatal myocardial infarction, heart failure, or nonfatal stroke)
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
patients with type 2 diabetes who were evaluated hemoglobin, renal function and urinary albumin excretion
Key exclusion criteria
patients using SGLT2 inhibitors or GLP-1 receptor agonists
Target sample size
700
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
03-3673-1221
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
03-3673-1221
Homepage URL
ito@edogawa.or.jp
Sponsor or person
Institute
Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital
Address
Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital
Tel
03-3673-1221
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
| 2022 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s13340-023-00637-x
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s13340-023-00637-x
Number of participants that the trial has enrolled
778
Results
The incidence of cardiovascular and renal events was found to be 5% and 11%, respectively. Even after adjusting for eGFR, the incidence of cardiovascular events was significantly higher in patients with anemia and albuminuria than in those without anemia and albuminuria. The incidence of renal events was significantly higher in patients with no anemia and albuminuria and further in those with anemia and albuminuria than in those without anemia and albuminuria even after adjusting for a reduced eGFR.
Results date posted
| 2024 | Year | 01 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 05 | Month | 30 | Day |
Baseline Characteristics
778 patients with type 2 diabetes
Participant flow
778 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 | 08 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study
Management information
Registered date
| 2022 | Year | 04 | Month | 30 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054314
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