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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039972
Receipt No. R000045574
Scientific Title Protein-bound uremic toxins and nutritional status in hemodialysis patients
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/29

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Basic information
Public title Protein-bound uremic toxins and nutritional status in hemodialysis patients
Acronym Protein-bound uremic toxins and nutritional status in hemodialysis patients
Scientific Title Protein-bound uremic toxins and nutritional status in hemodialysis patients
Scientific Title:Acronym Protein-bound uremic toxins and nutritional status in hemodialysis patients
Region
Japan

Condition
Condition Maintenance hemodialysis patients
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the associations between serum level of protein-bound uremic toxins and several nutritional markers in maintenance hemodilaysis patients
Basic objectives2 Others
Basic objectives -Others Dietary intake of protein will improve nutritional status in hemodialysis patients, while it may increase the production of uremic toxins.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum level of protein-bound uremic toxins including indoxy sulfate, p-cresyl sulfate, indole acetic acid, and phenyl sulfate), and nutritional indicators including serum level of albumin, creatinine, GNRI, and nPCR.
Key secondary outcomes

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 undergoing maintenance hemodialysis treatment
Key exclusion criteria Patients who are not undergoing maintenance hemodialysis treatment
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Suguru
Middle name Yamamoto
Last name Yamamoto
Organization Niigata university medical and dental hospital
Division name Division of Blood Purification Therapy
Zip code 951-8520
Address 1-757 Asahimachi-dori, Niigata 951-8510
TEL 0252272770
Email 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 Division of Blood Purification Therapy
Zip code 950-8510
Address 1-757 Asahimachi-dori, Niigata 951-8510
TEL 0252272770
Homepage URL
Email yamamots@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization N/A
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 Niigata University
Address 1-757 Asahimachi-dori, Niigata 951-8510
Tel 0252272770
Email 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
2020 Year 04 Month 01 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 200
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
2019 Year 05 Month 16 Day
Date of IRB
2019 Year 05 Month 16 Day
Anticipated trial start date
2019 Year 05 Month 16 Day
Last follow-up date
2020 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a cross-sectional study, and the data has been already available.

Management information
Registered date
2020 Year 03 Month 29 Day
Last modified on
2020 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045574

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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