UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036914 |
|---|---|
| Receipt number | R000042067 |
| Scientific Title | The analysis of the gut microbiota in chronic kidney disease |
| Date of disclosure of the study information | 2019/06/05 |
| Last modified on | 2019/05/31 18:35:26 |
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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
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
kasanuma@chiba-u.jp
Public contact
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
hawakaba@chiba-u.jp
Sponsor or person
Institute
Graduate school of Medicine, Chiba University,Department of Nephrology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042067
