UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003730 |
|---|---|
| Receipt number | 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 09:18:44 |
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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
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
m-koremoto@umin.ac.jp
Sponsor or person
Institute
E-HOPED-STUDY GROUP
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004510
