UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009834 |
|---|---|
| Receipt number | R000011439 |
| Scientific Title | Research project about the efficacy of the instruction manual for the living and the dietary to prevent exacerbation of kidney diseases |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2015/07/24 10:04:52 |
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Basic information
Public title
Research project about the efficacy of the instruction manual for the living and the dietary to prevent exacerbation of kidney diseases
Acronym
The practical project to prevent exacerbation of kidney diseases
Scientific Title
Research project about the efficacy of the instruction manual for the living and the dietary to prevent exacerbation of kidney diseases
Scientific Title:Acronym
The practical project to prevent exacerbation of kidney diseases
Region
| Japan |
Condition
Condition
Chronic kidney disease stage 1-4
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To modify and evaluate the efficacy of the instruction manual for the living and dietary to prevent exacervation of chronic kidney disease made by the strategic study group for the prevention of exacervation of kidney diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Change of estimated glomerular filtration rate (eGFR) with creatinine
2 Change of eGFR with cystatin-C
3 Change of urinary albumin excretion
4 Change of proteinuria
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom | Other |
Interventions/Control_1
The living and dietary instruction
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients who have a medical examination regularly once in 1-3 months
2 Patients who measure home blood pressure (morning, before sleep)
Key exclusion criteria
1 Patients who do not adhere rigidly to instruction
2 Patients judged inadequate by a responsible physician
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Takahashi |
Organization
International Kidney Evaluation Association Japan
Division name
Director-General
Zip code
Address
#702, 3-25 Ichigaya-honmuracho, Shinjuku-ku, Tokyo, 162-0845 Japan
TEL
03-5579-8115
takahashi.s@ikeaj.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko MIiyaguchi |
Organization
International Kidney Evaluation Association Japan
Division name
Secretariat office
Zip code
Address
#702 Ichigaya Linden Bldg, Ichigayahonmuracho 3-25 Shinjukuku, Tokyo 162-0845 JAPAN TEL +81-3-5579-8
TEL
03-5579-8115
Homepage URL
miyaguchi@ikeaj.or.jp
Sponsor or person
Institute
International Kidney Evaluation Association Japan
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 22 | Day |
Last modified on
| 2015 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011439
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
