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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035264
Receipt No. R000040174
Scientific Title Proteomic analysis of Lixelle-adsorbed proteins
Date of disclosure of the study information 2018/12/15
Last modified on 2018/12/14

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Basic information
Public title Proteomic analysis of Lixelle-adsorbed proteins
Acronym Proteomic analysis of Lixelle-adsorbed proteins
Scientific Title Proteomic analysis of Lixelle-adsorbed proteins
Scientific Title:Acronym Proteomic analysis of Lixelle-adsorbed proteins
Region
Japan

Condition
Condition Chronic kidney disease, Dialysis-related amyloidosis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify the proteins adsorbed to Lixelle column.
To compare the removal effect of the Lixelle-adsorbed proteins with conventional hemodialysis and hemodiafiltration
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proteins adsorbed to Lixelle column
Key secondary outcomes Removal effect of Lixelle-adsorbed proteins in circulating blood.

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
100 years-old >
Gender Male and Female
Key inclusion criteria Maintenance hemodialysis patients who agree this research plan
Key exclusion criteria Non hemodialysis patients.
Hemodialysis patients who are not agree this research plan.
Target sample size 60

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 951-8520, Japan
TEL 0252272200
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 951-8520, Japan
TEL 0252272200
Homepage URL
Email yamamots@med.niigata-u.ac.jp

Sponsor
Institute Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization Kaneka Medix Corp.
Organization
Division
Category of Funding Organization Profit organization
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 12 Month 15 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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a cross sectional study.
1. Proteomic anaylysis of Lixelle adsorbed molecules.
2. Comarison of removal effect of Lixelle-adsorbed proteins by Lixelle-hemodialysis
with hemodialysis and hemodiafiltration.

Management information
Registered date
2018 Year 12 Month 14 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040174

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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