UMIN-CTR Clinical Trial

Basic information
Public title	The analysis of the gut microbiota in chronic kidney disease
Acronym	The analysis of the gut microbiota in chronic kidney disease
Scientific Title	The analysis of the gut microbiota in chronic kidney disease
Scientific Title:Acronym	The analysis of the gut microbiota in chronic kidney disease
Region	Japan

Condition
Condition	chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to develop new therapeutic strategies aimed at improving the renal prognosis and life prognosis of chronic kidney disease (CKD).
Basic objectives2	Others
Basic objectives -Others	For patients with advanced CKD (Stage 3-5), using blood samples and feces, characteristics of intestinal microbiota in CKD patients, intestinal microbiota and urinary toxin substance in blood, inflammatory / suppressive cytokines, To clarify the relationship between immunocompetent cells, CKD progression and risk of complications.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify the characteristics of intestinal flora of kidney disease patients
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Age; Men and women at the age of 20 and older at the time of consent acquisition 2) Admission and outpatients: Inpatient and outpatient 3) CKD stages 3-5 in hospital 4) Patients who can freely participate in written informed consent (or consented by a representative if they do not have the ability to make decisions by themselves)
Key exclusion criteria	1) Patients who can not get consent 2) A person judged to be inappropriate as a subject by the research principal doctor or research doctor
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name katsuhiko Middle name Last name Asanuma
Organization	Graduate school of Medicine, Chiba University
Division name	Department of Nephrology
Zip code	2608677
Address	1-8-1 Inohana Chuo-ku Chiba City, Chiba, Japan
TEL	0432227171
Email	kasanuma@chiba-u.jp

Public contact
1st name of contact person	1st name Hanae Middle name Last name Wakabayashi
Organization	Graduate school of Medicine, Chiba University
Division name	Department of Nephrology
Zip code	2608677
Address	1-8-1 Inohana Chuo-ku Chiba City, Chiba, Japan
TEL	0432227171
Homepage URL
Email	hawakaba@chiba-u.jp

Sponsor
Institute	Graduate school of Medicine, Chiba University,Department of Nephrology
Institute
Department

Funding Source
Organization	Graduate school of Medicine, Chiba University,Department of Nephrology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate school of Medicine, Chiba University
Address	1-8-1 Inohana, Chuo-ku,Chiba city,Chiba.Japan
Tel	0432227171
Email	igaku-rinri@office.chiba-u.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

Other administrative information
Date of disclosure of the study information	2019 Year 06 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	Preinitiation
Date of protocol fixation	2019 Year 04 Month 01 Day
Date of IRB	2018 Year 10 Month 04 Day
Anticipated trial start date	2019 Year 06 Month 03 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 05 Month 31 Day
Last modified on	2019 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042067