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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025728
Receipt No. R000029599
Scientific Title Effect of different high performance membrane dualyzers on survival in chronic hemodialysis patients
Date of disclosure of the study information 2018/12/31
Last modified on 2017/01/18

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Basic information
Public title Effect of different high performance membrane dualyzers on survival in chronic hemodialysis patients
Acronym Dialyzers on HD patients
Scientific Title Effect of different high performance membrane dualyzers on survival in chronic hemodialysis patients
Scientific Title:Acronym Dialyzers on HD patients
Region
Japan

Condition
Condition Ptients on hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish the association between different dialyzer membranes and mortality rates in patients on hemodialysis
Basic objectives2 Others
Basic objectives -Others To estimate the predictors for mortality in patients on dialysis
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Mortality
Key secondary outcomes

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients who had received maintenance dialysis between December 2008 and December 20012. 2)Patients who were received maintenance hemodialysis thrice a week, who had received maintenance dialysis for at least 2 years at the end of the year 2008, 3)and who were treated with seven major dialyzers, namely, cellulose triacetate (CTA), ethylene vinyl alcohol (EVAL), polyacrylonitrile (PAN), polyester polymer alloy (PEPA), polyethersulfone (PES), polymethylmethacrylate (PMMA), and polysulfone (PS) membranes.
Key exclusion criteria Patients who had been dialyzed fewer than three times a week or fewer than two hours per treatment, who had treated with other than above mentioned major 7 dialyzers, those who had received peritoneal dialysis, those with a history of organ transplantation, age < 18 years old, and those whose records covering date of birth, dialysis initiation, or outcome were incomplete.
Target sample size 140000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Abe
Organization Japanese Society for Dialysis Therapy
Division name The Committee of Renal Data Registry
Zip code
Address 2-38-21, Hongo, Bunkyou-ku, Tokyo, Japan
TEL 03-5800-0786
Email abe.masanori@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Abe
Organization Nihon University School of Medicine
Division name Nephrology, Hypertension and Endocrinology
Zip code
Address 30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, 173-8610, Japan
TEL 03-3972-8111
Homepage URL
Email abe.masanori@nihon-u.ac.jp

Sponsor
Institute Japanese Society for Dialysis Therapy
Institute
Department

Funding Source
Organization None
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 12 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
2016 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The data were obtained from the annual nationwide surveys of dialysis patients which is Japanese Renal Data Registry (JRDR) system conducted by the Japanese Society for Dialysis Therapy (JSDT). The surveys were conducted by JSDT volunteers, with details described previously. Briefly, data covered 282,622 patients receiving hemodialysis at 4,072 facilities in the 2008 survey, and 290,675 patients at 4,125 facilities in the 2009 survey. The study population consisted of patients who had received maintenance dialysis between December 2008 and December 2012.

Management information
Registered date
2017 Year 01 Month 18 Day
Last modified on
2017 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029599

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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