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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026854
Receipt No. R000030817
Scientific Title Efficacy of educational program for patients with chronic kidney disease.
Date of disclosure of the study information 2017/04/05
Last modified on 2017/10/23

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Basic information
Public title Efficacy of educational program for patients with chronic kidney disease.
Acronym Efficacy of educational program for patients with chronic kidney disease.
Scientific Title Efficacy of educational program for patients with chronic kidney disease.
Scientific Title:Acronym Efficacy of educational program for patients with 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 asses the efficacy of educational hospitalization program for patients with CKD
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes % change of eGFR at 1 year
Key secondary outcomes continuous rate of diet therapy and exercise training

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 dietary therapy, exercise training,
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
75 years-old >=
Gender Male and Female
Key inclusion criteria CKD stage 3b-5
Key exclusion criteria proteinuria of nephrotic range, severe obesity, cachexia, uncontrolled dibates, liver cirrhosis, severe cardiac failure.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinobu Sato
Organization Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Division name Department of Nephrology
Zip code
Address 3-16-1, Tsutsumi-machi, Aoba-ku, Sendai, Miyagi 981-8501, Japan.
TEL 022-275-3111
Email sato-toshinobu@sendai.jcho.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Ishiyama
Organization Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Division name Department of Nephrology
Zip code
Address 3-16-1, Tsutsumi-machi, Aoba-ku, Sendai, Miyagi 981-8501, Japan.
TEL 022-275-3111
Homepage URL
Email ishiyama-katsuya@sendai.jcho.go.jp

Sponsor
Institute Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Institute
Department

Funding Source
Organization Miyagi Kidney Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2017 Year 04 Month 05 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 05 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
2024 Year 03 Month 31 Day
Date trial data considered complete
2024 Year 09 Month 30 Day
Date analysis concluded
2025 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 04 Month 04 Day
Last modified on
2017 Year 10 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030817

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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