UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Direct hemoperfusion of protein-bound uremic toxins
Title of the study (Brief title)	Protein-bound uremic toxin adsorption from blood
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 examine adsorption of protein-bound uremic toxins with direct hemoperfusion using charcoal adsorbent in vitro
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of blood level of several protein-bound uremic toxins in vitro
Key secondary outcomes	Change of other uremic toxins and electrolytes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Chronic kidney disease patients undergoing maintenance hemodialysis treatment
Key exclusion criteria	Patients who treat infection. Pregnancy. Duration of dialysis treatment less than 1 year.
Target sample size	10

Research contact person
Name of lead principal investigator	Suguru Yamamoto
Organization	Niigata University Medical and Dental Hospital
Division name	Division of Blood Purification Therapy
Address	1-754 Asahimachi-dori, Chuou-ku, Niigata, 951-8520
TEL	025-227-2770
Email	yamamots@med.niigata-u.ac.jp

Public contact
Name of contact person	Suguru Yamamoto
Organization	Niigata University Medical and Dental Hospital
Division name	Division of Blood Purification Therapy
Address	1-754 Asahimachi-dori, Chuou-ku, Niigata, 951-8520
TEL	025-227-2770
Homepage URL
Email	yamamots@med.niigata-u.ac.jp

Sponsor
Institute	Division of Blood Purification Therapy, Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization	N/A
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kureha Corporation,
Name of secondary funｄer(s)

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	新潟大学医歯学総合病院（新潟）

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 10 Day
Anticipated trial start date	2017 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We'll collect blood from hemodialysis patients and examine an in vitro direct hemoperfusion using charcoal for protein-bound uremic toxins.

Management information
Registered date	2017 Year 07 Month 31 Day
Last modified on	2018 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029445