UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034240 |
|---|---|
| Receipt number | R000039032 |
| Scientific Title | Cognitive function and uremic toxins |
| Date of disclosure of the study information | 2018/09/22 |
| Last modified on | 2020/09/23 18:08:29 |
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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 | Suguru |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Medical and Dental Hospital
Division name
Blood purification therapy
Zip code
951-8520
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata, Japan 951-8520
TEL
025-227-2770
yamamots@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Medical and Dental Hospital
Division name
Blood purification therapy
Zip code
951-8520
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata, Japan 951-8520
TEL
025-227-2770
Homepage URL
yamamots@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
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
Niigata University Medical and Dental Hospital
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata, Japan 951-8520
Tel
0252276161
yamamots@med.niigata-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
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
1220
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 23 | Day |
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
| 2020 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.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 |
