UMIN-CTR Clinical Trial

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

Renal failure

Classification by specialty

Medicine in general	Endocrinology and Metabolism	Nephrology
Urology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

E-HOPED-STUDY GROUP

Institute

Department

Personal name

Organization

Asahi Kasei Medical Co., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）。

Date of disclosure of the study information

2010

Year

06

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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