UMIN-CTR Clinical Trial

Basic information
Public title	Removal of protein-bound uremic toxins by acetate-free biofiltraition in dialysis patients
Acronym	AFBF and uremic toxins
Scientific Title	Removal of protein-bound uremic toxins by acetate-free biofiltraition in dialysis patients
Scientific Title:Acronym	AFBF and uremic toxins
Region	Japan

Condition
Condition	End-stage kidney disease patients undergoing dialysis treatment
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To understand whether acetate-free biofiltration removes more protein-bound uremic toxins than regular hemodialysis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of serum uremic toxins level
Key secondary outcomes	Removal of uremic toxins with hemodialyzer

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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing maintenance hemodialysis
Key exclusion criteria	Patients who do not agree informed consent. Patients who have hospitalization owing to cardiovascular disease, malignancy and infectious disease during 6 months. Pregnant women
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Yamamoto
Organization	Niigata University Medical and Dental Hospital
Division name	Division of Blood Purification Therapy
Zip code	951-8520
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL	025-227-2200
Email	yamamots@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Suguru Middle name Last name Yamamoto
Organization	Niigata University Medical and Dental Hospital
Division name	Division of Blood Purification Therapy
Zip code	951-8520
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL	025-227-2200
Homepage URL
Email	yamamots@med.niigata-u.ac.jp

Sponsor
Institute	Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Science, 1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
Institute
Department

Funding Source
Organization	Niigata University Medical and Dental Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Niigata University Medical and Dental Hospital
Address	1-757 Asahimachi-dori, Niigata 951-8510
Tel	0252272200
Email	ethics@adm.niigata-u.ac.jp

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 07 Month 29 Day

Related information
URL releasing protocol	NA
Publication of results	Unpublished

Result
URL related to results and publications	NA
Number of participants that the trial has enrolled	20
Results	Use of acetate-free biofiltration method did not increase the removal of uremic toxins in end-stage kidney disease patients.
Results date posted	2021 Year 08 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	End-stage kidney disease patients undergoing regular hemodialysis, hemodiafiltration and hemodialysis using acetate-free biofiltration method.
Participant flow	Those patients joined this study.
Adverse events	NA
Outcome measures	Serum levels of several uremic toxins.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 01 Month 14 Day
Date of IRB	2015 Year 12 Month 21 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2020 Year 07 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Comparison of serum uremic toxins level in before/after treatment as well as before/after passing the column between acetate-free biofiltration and regular hemodialysis treatment.

Management information
Registered date	2016 Year 07 Month 29 Day
Last modified on	2022 Year 08 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026958