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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028465
Receipt No. R000029445
Scientific Title Direct hemoperfusion of protein-bound uremic toxins
Date of disclosure of the study information 2017/07/31
Last modified on 2018/06/04

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Basic information
Public title Direct hemoperfusion of protein-bound uremic toxins
Acronym Protein-bound uremic toxin adsorption from blood
Scientific Title Direct hemoperfusion of protein-bound uremic toxins
Scientific Title:Acronym Protein-bound uremic toxin adsorption from blood
Region
Japan

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

Objectives
Narrative objectives1 To examine adsorption of protein-bound uremic toxins with direct hemoperfusion using charcoal adsorbent in vitro
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of blood level of several protein-bound uremic toxins in vitro
Key secondary outcomes Change of other uremic toxins and electrolytes

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
80 years-old >
Gender Male and Female
Key inclusion criteria Chronic kidney disease patients undergoing maintenance hemodialysis treatment
Key exclusion criteria Patients who treat infection.
Pregnancy.
Duration of dialysis treatment less than 1 year.
Target sample size 10

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 Division of Blood Purification Therapy
Zip code
Address 1-754 Asahimachi-dori, Chuou-ku, Niigata, 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 Division of Blood Purification Therapy
Zip code
Address 1-754 Asahimachi-dori, Chuou-ku, Niigata, 951-8520
TEL 025-227-2770
Homepage URL
Email yamamots@med.niigata-u.ac.jp

Sponsor
Institute Division of Blood Purification Therapy, Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kureha Corporation,
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 新潟大学医歯学総合病院(新潟)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 31 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 Completed
Date of protocol fixation
2017 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We'll collect blood from hemodialysis patients and examine an in vitro direct hemoperfusion using charcoal for protein-bound uremic toxins.

Management information
Registered date
2017 Year 07 Month 31 Day
Last modified on
2018 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029445

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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