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Recruitment status Completed
Unique ID issued by UMIN UMIN000015174
Receipt No. R000017644
Scientific Title Serum albumin-adjusted glycated albumin is a useful indicator of glycemic control in diabetic patients with end-stage renal disease not on hemodialysis
Date of disclosure of the study information 2014/09/16
Last modified on 2017/07/03

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Basic information
Public title Serum albumin-adjusted glycated albumin is a useful indicator of glycemic control in diabetic patients with end-stage renal disease not on hemodialysis
Acronym Albumin adjusted GA for DM with ESRD
Scientific Title Serum albumin-adjusted glycated albumin is a useful indicator of glycemic control in diabetic patients with end-stage renal disease not on hemodialysis
Scientific Title:Acronym Albumin adjusted GA for DM with ESRD
Region
Japan

Condition
Condition Patients with diabetic nephropathy CKD4-5
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we examined whether serum albumin (SA)-adjusted GA (adjGA) could accurately reflect glycemic control in these patients.
Basic objectives2 Others
Basic objectives -Others Association between GA and glycemic control
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between SA-adjusted GA and glycemic control
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diabetic nephropathy CKD stage 4-5 not on HD
Key exclusion criteria cancer
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kei Fukami
Organization Department of Medicine, Kurume University School of Medicine
Division name Division of Nephrology
Zip code
Address 67 Asahi-machi Kurume city Fukuoka Japan
TEL 0942-35-3311
Email fukami@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kei Fukami
Organization Department of Medicine, Kurume University School of Medicine
Division name Division of Nephrology
Zip code
Address 67 Asahi-machi Kurume city Fukuoka Japan
TEL 0942-35-3311
Homepage URL
Email fukami@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Kurume University School of Medicine
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
Address
Tel
Email

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
2014 Year 09 Month 16 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
2014 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 13 Day
Last follow-up date
Date of closure to data entry
2014 Year 09 Month 28 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Obtain glycemic markers and examine the association between GA and SA-adjusted GA in these patients.

Management information
Registered date
2014 Year 09 Month 16 Day
Last modified on
2017 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017644


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