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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000047632
Receipt No. 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 2022/04/30

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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
Email 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
Email ito@edogawa.or.jp

Sponsor
Institute Department of Diabetes, Metabolism and Kidney Disease, Edogawa Hospital
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 778
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
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
2022 Year 04 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054314

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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