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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003730
Receipt No. R000004510
Scientific Title The effect of hemodialyzer characteristics on the prognosis of elderly dialysis patients with early dialysis stage
Date of disclosure of the study information 2010/06/09
Last modified on 2014/06/09

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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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