UMIN-CTR Clinical Trial

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
Email	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
Email	shuwakino@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055262