UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029858 |
|---|---|
| Receipt number | R000034099 |
| Scientific Title | Study of the risk factors for the progression of diabetic kidney disease |
| Date of disclosure of the study information | 2017/11/07 |
| Last modified on | 2017/11/07 12:13:07 |
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Basic information
Public title
Study of the risk factors for the progression of diabetic kidney disease
Acronym
DKD study
Scientific Title
Study of the risk factors for the progression of diabetic kidney disease
Scientific Title:Acronym
DKD study
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure molecules, which are expected to be involved in renal function failure using blood and urine and to examine correlations with various clinical data.
Basic objectives2
Others
Basic objectives -Others
Measuring of urinary podocalyxin.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At the time of patient registration, registration (0 M), 12 M, 24 M, 36 M, the following indices are measured. Vitamin D, PTH, AcSDKP, Type IV C, Bteta-2MG, Kim 1, Ngal, 8OHDG, eGFR, UACR, U-podocalyxin.
Also, we will also measure urinary podocalyxin (PCX) at the time of visit only for patients who obtained permission.
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
Type 2 diabetes mellitus
Key exclusion criteria
Under 20 y/o
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Toyoda |
Organization
Department of Internal Medicine, Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL
0463-93-1121
m-toyoda@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwamatsu kanori |
Organization
Department of Internal Medicine, Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL
0463-93-1121
Homepage URL
k-iwamstu@tsc.u-tokai.ac.jp
Sponsor or person
Institute
Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai 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)
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
| 2017 | Year | 11 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NONE
Management information
Registered date
| 2017 | Year | 11 | Month | 07 | Day |
Last modified on
| 2017 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034099
