UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Serum Glycated Albumin on Survival in Diabetic Patients Undergoing Hemodialysis
Title of the study (Brief title)	Serum Glycated Albumin on Survival in Diabetes
Region	Japan

Condition
Condition	Diabetic nephropathy
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effects of serum glycated albumin, hemoglobin, and glucose on survival in diabetic patients undergoing hemodialysis
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient death
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Diabetic patients 20years or older who are undergoing hemodialysis
Key exclusion criteria	1.Dialysis vintage less than 6 months 2. Liver cirrhosis or hepatocellular carcinoma 3. Hypo- and hyperthyroidism 4. Malignant disease 5. Active infection
Target sample size	1000

Research contact person
Name of lead principal investigator	Yasuko Uchigata
Organization	Tokyo Women's Medical University
Division name	Diabetes Center
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-8111
Email	uchigata.dmc@twmu.ac.jp

Public contact
Name of contact person	Ko Hanai
Organization	Tokyo Women's Medial University School of Medicine
Division name	Diabetes Center
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-8111
Homepage URL
Email	hanai.dmc@twmu.ac.jp

Sponsor
Institute	Diabetes Center, Tokyo Women's Medial University School of Medicine
Institute
Department

Funding Source
Organization	Diabetes Center, Tokyo Women's Medial University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2012 Year 10 Month 03 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2012 Year 09 Month 30 Day
Anticipated trial start date	2012 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Follow-up for 5 years

Management information
Registered date	2012 Year 10 Month 03 Day
Last modified on	2016 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010604