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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034240
Receipt No. R000039032
Scientific Title Cognitive function and uremic toxins
Date of disclosure of the study information 2018/09/22
Last modified on 2018/09/22

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Basic information
Public title Cognitive function and uremic toxins
Acronym Cognitive function and uremic toxins
Scientific Title Cognitive function and uremic toxins
Scientific Title:Acronym Cognitive function and uremic toxins
Region
Japan

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

Objectives
Narrative objectives1 To understand the association between cognitive function and serum level of uremic toxins in chronic kidney disease (CKD) patients.
Basic objectives2 Others
Basic objectives -Others CKD patients show congitive disorder while the mechanism is incompletely understood. Uremic toxins induce various CKD-related systemic disease, and those may be associated with cognitive disorders in CKD patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mini Mental State Examination (MMSE) for cognitive function and serum level of uremic toxins. A cross-sectinal study.
Key secondary outcomes MMSE and CKD stage/ dialysis vintage

Base
Study type Others,meta-analysis etc

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
100 years-old >
Gender Male and Female
Key inclusion criteria Patients who join PROject in Sado for Total health (PROST) study.
Key exclusion criteria Patients who join PROST study at the age less 20 and more than 100 years old.
Patients who was judged not proper to join the study by the principal investigator.
Target sample size 1890

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Suguru Yamamoto
Organization Niigata University Medical and Dental Hospital
Division name Blood purification therapy
Zip code
Address 1-754 Asahimachi-dori, Chuo-ku, Niigata, Japan 951-8520
TEL 025-227-2770
Email yamamots@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Suguru Yamamoto
Organization Niigata University Medical and Dental Hospital
Division name Blood purification therapy
Zip code
Address 1-754 Asahimachi-dori, Chuo-ku, Niigata, Japan 951-8520
TEL 025-227-2770
Homepage URL
Email yamamots@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 09 Month 22 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
2018 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A cross-sectional study to understand an association between MMSE and serum level of various uremic toxins.

Management information
Registered date
2018 Year 09 Month 22 Day
Last modified on
2018 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039032

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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