UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026854 |
|---|---|
| Receipt number | 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 13:15:03 |
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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
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
ishiyama-katsuya@sendai.jcho.go.jp
Sponsor or person
Institute
Incorporated administrative agency, Japan Community Health care Organization, Sendai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030817
| 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 |
