UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014928 |
|---|---|
| Receipt number | R000017371 |
| Scientific Title | Regional nutritional and habital guidance for preventing aggravation of chronic kidney disease |
| Date of disclosure of the study information | 2014/08/23 |
| Last modified on | 2023/04/08 02:19:05 |
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Basic information
Public title
Regional nutritional and habital guidance for preventing aggravation of chronic kidney disease
Acronym
Regional nutritional and habital guidance for preventing aggravation of chronic kidney disease
Scientific Title
Regional nutritional and habital guidance for preventing aggravation of chronic kidney disease
Scientific Title:Acronym
Regional nutritional and habital guidance for preventing aggravation of chronic kidney disease
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect the data for establishment of regional nutritional and habital guidance in chronic kidney disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
One of the follwing outcomes; BMI,blood pressure, HbA1c, salt intake ,
protein intake, serum potassium. medication adherence
Key secondary outcomes
The outcomes which were not selected as a primary outcomes, and number of cigarette smoked, LDL-cholesterol, urin acid, daily steps in pedometer.
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
CKD stage G3
Key exclusion criteria
Patients who is thought to be ill-qualified for this study
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiichi Matsuo |
Organization
Japanese Society of Nephrology
Division name
The secretariat
Zip code
Address
Nichinai Kaikan, 3-28-8, Hongou, Bunkyo-ku, Tokyo
TEL
03-5842-4131
office@jsn.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiro Yamagata |
Organization
University of Tsukuba
Division name
Department of Nephrology, Faculty of medicine,
Zip code
Address
1-1-1, Ten-nodai, Tsukuba, Ibaraki
TEL
029-853-3202
Homepage URL
fromj-kid@med.tsukuba.ac.jp
Sponsor or person
Institute
Japanese Society of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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 | 08 | Month | 23 | 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 | 07 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
A prospective cohort study
Management information
Registered date
| 2014 | Year | 08 | Month | 23 | Day |
Last modified on
| 2023 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017371
