UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of different high performance membrane dualyzers on survival in chronic hemodialysis patients
Title of the study (Brief title)	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	Masanori Abe
Organization	Japanese Society for Dialysis Therapy
Division name	The Committee of Renal Data Registry
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	Masanori Abe
Organization	Nihon University School of Medicine
Division name	Nephrology, Hypertension and Endocrinology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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