UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048522 |
|---|---|
| Receipt number | R000055262 |
| Scientific Title | The effects of low protein Genmai in CKD patients-Study on Kidney-gut axis- |
| Date of disclosure of the study information | 2022/08/15 |
| Last modified on | 2022/07/30 06:04:03 |
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Basic information
Public title
The effects of low protein Genmai in CKD patients
Acronym
Low protein Genmai study
Scientific Title
The effects of low protein Genmai in CKD patients-Study on Kidney-gut axis-
Scientific Title:Acronym
Kidney-gut axis study
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the change in clinical parameters by the low-protein brown rice
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
subjective findings, QOL
renal function
urinalysis
stool examination
Key secondary outcomes
Cytokine levels
uremic toxin levels
gut microbiota population
electrolytes
defecation comdition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
low protein brown rice
Interventions/Control_2
usual low protein diret
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) CKD patient at stage 3 over
2) never experienced diet therapy
3) have given us an infoemed consent
Key exclusion criteria
1) cannot be got a sufficient materials
2) cannot understand the significance of diet therapy
3) have an inflammatory bowel disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shu |
| Middle name | |
| Last name | Wakino |
Organization
Tokushima University Graduate School
Division name
Department of Nephrology
Zip code
770-8503
Address
3-18-15, Kuramoto, Tokushima
TEL
088-633-7183
shuwakino@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shu |
| Middle name | |
| Last name | Wakino |
Organization
Tokushima University Graduate School
Division name
Department of Nephrology
Zip code
770-8503
Address
3-18-15, Kuramoto, Tokushima
TEL
088-633-7183
Homepage URL
shuwakino@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Cabinet Office
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Medical Rice Association
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1, Kuramoto, Tokushima
Tel
088-633-9294
awachiken@tokushima-u.ac.jp
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
徳島大学病院（徳島県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 30 | Day |
Last modified on
| 2022 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055262
