UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015174 |
|---|---|
| Receipt number | 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 09:33:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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 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
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
fukami@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017644
