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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009834
Receipt No. 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

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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
Email 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
Email miyaguchi@ikeaj.or.jp

Sponsor
Institute International Kidney Evaluation Association Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011439

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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