UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021281
Receipt number R000024546
Scientific Title About serum beta2-microglobulin density and life prognostic connection
Date of disclosure of the study information 2016/03/02
Last modified on 2018/06/16 09:17:04

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Basic information

Public title

About serum beta2-microglobulin density and life prognostic connection

Acronym

About serum beta2-microglobulin density and life prognostic connection

Scientific Title

About serum beta2-microglobulin density and life prognostic connection

Scientific Title:Acronym

About serum beta2-microglobulin density and life prognostic connection

Region

Japan


Condition

Condition

dialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It is forward and judges whether connection is seen in serum beta 2 microglobulin density and life convalescence by the intervention on the dialysis condition

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1.The death rate
2.The number of the cardiovascular events
3.The number of the cerebrovascular events

Key secondary outcomes

1.Other clinical inspection level
2.Pain with the amyloid


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Change a dialysis condition to a hard condition

Interventions/Control_2

Treat it by normal dialysis

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Dialysis patient with more than regular 30 mg/L of serum beta 2 microglobulin density

Key exclusion criteria

Patient with cancer
Patient with CRP where there is remarkable inflammation more than 2
The patient who uses blood catharsis except hemodialysis therapy or the hemodialysis filtration therapy together
During the pregnancy or the patient whom I am nursing
The patient who has a high disability in the liver, a heart, the lungs






Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yusaku Tanaka

Organization

Kawashima Hospital

Division name

Clinical department of engineering

Zip code


Address

1-1-39 Kitasako, Tokusima, 770-8548, Japan

TEL

088-631-0110

Email

tanakayusaku0724@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Yusaku Tanaka

Organization

Kawashima Hospital

Division name

Clinical department of engineering

Zip code


Address

1-1-39 Kitasako, Tokusima, 770-8548, Japan

TEL

088-631-0110

Homepage URL


Email

tanakayusaku0724@gmail.com


Sponsor or person

Institute

Kawashima Hospital

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 02 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2015 Year 12 Month 20 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 15 Day

Last follow-up date

2018 Year 03 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

2016 Year 03 Month 02 Day

Last modified on

2018 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024546


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name