UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014744
Receipt number R000017139
Scientific Title Blood purification treatments for removal of protein-bound uremic toxins
Date of disclosure of the study information 2014/08/05
Last modified on 2016/02/01 19:40:10

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Basic information

Public title

Blood purification treatments for removal of protein-bound uremic toxins

Acronym

Blood purification treatments for removal of protein-bound uremic toxins

Scientific Title

Blood purification treatments for removal of protein-bound uremic toxins

Scientific Title:Acronym

Blood purification treatments for removal of protein-bound uremic toxins

Region

Japan


Condition

Condition

Chronic kidney disease undergoing hemodialysis treatment

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate blood purification treatments with better removal of protein-bound uremic toxins

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Removal of several protein-bound uremic toxins

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Use of adsorption column (Lixelle S-35) with regular hemodialysis treatment for 6 times

Interventions/Control_2

Hemodialysis treatment using polymethyl methacrylate-dialyzer for 6 times

Interventions/Control_3

Hemodialysis treatment using polysulfone-dialyzer for 6 times

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

50 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with chronic kidney disease undergoing hemodialysis treatment for 5 to 10 years

Key exclusion criteria

1) Patients with pregnancy
2) Body weight less than 40 kg
3) Patients with allergic disease
4) Patients who have cardiovascular disease within one month

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Junichiro J. Kazama

Organization

Niigata University Medical and Dental Hospital

Division name

Blood Purification Center

Zip code


Address

1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan

TEL

0252272770

Email

jjkaz@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Suguru Yamamoto

Organization

Niigata University Graduate School of Medical and Dental Science

Division name

Clinical Nephroscience

Zip code


Address

1-757 Asahimachi-dori, Chuou-ku, Niigata, 951-8510Japan

TEL

0252270436

Homepage URL


Email

yamamots@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University Medical and Dental Hospital

Institute

Department

Personal name



Funding Source

Organization

Niigata University Medical and Dental Hospital

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 05 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

2013 Year 12 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 08 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 08 Month 01 Day

Last modified on

2016 Year 02 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017139


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name