UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030669
Receipt number R000035014
Scientific Title Comparison of removal efficacy of blood nucleic acids, phenol derivatives, xanthine derivatives and the mitochondrial functional marker in hemodialysis and online hemodiafiltration
Date of disclosure of the study information 2018/01/14
Last modified on 2019/08/25 14:37:00

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Basic information

Public title

Comparison of removal efficacy of blood nucleic acids, phenol derivatives, xanthine derivatives and the mitochondrial functional marker in hemodialysis and online hemodiafiltration

Acronym

Comparison of removal efficacy of blood nucleic acids, phenol derivatives, xanthine derivatives and the mitochondrial functional marker in hemodialysis and online hemodiafiltration

Scientific Title

Comparison of removal efficacy of blood nucleic acids, phenol derivatives, xanthine derivatives and the mitochondrial functional marker in hemodialysis and online hemodiafiltration

Scientific Title:Acronym

Comparison of removal efficacy of blood nucleic acids, phenol derivatives, xanthine derivatives and the mitochondrial functional marker in hemodialysis and online hemodiafiltration

Region

Japan


Condition

Condition

dialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to compare the removal efficacy of blood nucleic acids, phenol derivatives, xanthine derivatives and mitochondrial functional markers in hemodialysis and online hemodiafiltration.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The reduction ratio and total solute removal of blood nucleic acids (1-Methyladenosine, etc) and phenol derivatives (indoxylsulphate, p-cresylsulphate, etc) in hemodialysis and online hemodiafiltration.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

We change the dialysis method such as the hemodialysis, the pre-dilution hemodiafiltration and the post-dilution hemodiafiltration.

Interventions/Control_2


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

Stable chronic maintenance dialysis patients.

Key exclusion criteria

The patient who uses blood purification except for hemodialysis or hemodiafiltration together.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisato Shima

Organization

Kawashima hospital

Division name

Department of Kidney Disease

Zip code


Address

1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan

TEL

088-631-0110

Email

h.shima@khg.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisato Shima

Organization

Kawashima hospital

Division name

Department of Kidney Disease

Zip code


Address

1-39 Kitasakoichiban-cho, Tokushima city 770-0011, Tokushima, Japan

TEL

088-631-0110

Homepage URL


Email

h.shima@khg.or.jp


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

Tohoku University Hospital

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

2018 Year 01 Month 14 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

Completed

Date of protocol fixation

2017 Year 09 Month 05 Day

Date of IRB

2017 Year 09 Month 05 Day

Anticipated trial start date

2018 Year 01 Month 04 Day

Last follow-up date

2019 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

2018 Year 01 Month 04 Day

Last modified on

2019 Year 08 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035014


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name