UMIN-CTR Clinical Trial

Basic information
Public title	The effect of hemodialyzer characteristics on the prognosis of elderly dialysis patients with early dialysis stage
Acronym	E-HOPED STUDY
Scientific Title	The effect of hemodialyzer characteristics on the prognosis of elderly dialysis patients with early dialysis stage
Scientific Title:Acronym	E-HOPED STUDY
Region	Japan

Condition
Condition	Renal failure
Classification by specialty	Medicine in general Endocrinology and Metabolism Nephrology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect of high performance membrane or EVAL dialyzer on the prognosis of elderly dialysis patients with early dialysis stage.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	survival rate
Key secondary outcomes	cause of death, serum albumin, pre/post-dialysis serum creatinine, brain/cardiovascular event(included vascular access failure), rate of hospitalization, length of hospital stay, cause of hospitalization, newly complication, pre/post-dialysis body weight, blood pressure in pre/post-dialysis, dialysis condition, CTR, count of intradialytic first aid, residual urine volume, antihypertensive medication, pre/post-dialysis of BUN, body height, body mass index, geriatric nutritional risk index, CRP, beta-2 microglobulin, non-adjusted calcium, serum inorganic phosphate, intact-PTH

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Treatment with EVAL membrane dialyzer.
Interventions/Control_2	Treatment with high performance membrane dialyzer.
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All conditions are needed as inclusion criteria. 1)When patient are treated newly hemodialysis and 2-3 times consulted with hemodialysis, whose age isn't less than 70years old. 2)dialysis vintages is between 30 days and 179 days. 3)ambulatory patient. 4)no severe cardiovascular complication and no hospitalization. 5)few fementia. 6)provide written informed concent.
Key exclusion criteria	Someone condition is needed as exclusion criteria. 1)Primary disease is the following; rapidly progressive glomerulonephritis, pregnant toxicosis, polycystic kidney disease, amyloid kidney,microscopic polyangiitis, inborn error of metabolism based-renal failure, renal tumor, urinary tract tumor, obstructive uropathy, or myeloma. 2)Patient has been consulted with peritoneal dialysis. 3)Patient has been used vitamin E-bonded dialyzer. 4)Medical doctor judges patient who is unsuitble to registory on this study.
Target sample size	1600

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ikuto Masakane
Organization	Yabuki hospital
Division name	Internal medicine
Zip code
Address	1-6-17 honmachi, Yamagata-city, Yamagata, 990-0885, Japan
TEL	023-641-7330
Email	araki@seieig.or.jp

Public contact
Name of contact person	1st name Middle name Last name MASAHIDE KOREMOTO
Organization	E-HOPED-STUDY GROUP
Division name	Asahi Kasei Medical Co., LTD
Zip code
Address	1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo 101-8101, Japan
TEL	03-3296-3723
Homepage URL	http://www.e-hoped-study.com
Email	m-koremoto@umin.ac.jp

Sponsor
Institute	E-HOPED-STUDY GROUP
Institute
Department

Funding Source
Organization	Asahi Kasei Medical Co., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	http://www.e-hoped-study.com/list/ をご参照願います（サーバー内表示容量の関係で省略させて頂きます）。

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 09 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	No longer recruiting
Date of protocol fixation	2010 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date	2010 Year 07 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 06 Month 09 Day
Last modified on	2014 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004510

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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