UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Performance comparison of hollow-fiber dialyzers, VPS-VA and VPS-HA
Title of the study (Brief title)	Clinical Study of VPS-VA
Region	Japan

Condition
Condition	Chronic Kidney Disease (End Stage Renal Disease)
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate the beta 2-microglobulin clearance of VPS-VA is higher than that of VPS-HA.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Beta 2-microglobulin clearance
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	Device,equipment
Interventions/Control_1	Dialysis therapy using VPS-HA for a week. Hollow-fiber dialyzers will be changed from VPS-HA to VPS-VA. Dialysis therapy using VPS-VA for two weeks.
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients on stable maintenance dialysis therapy using VPS-HA at least three months. 2)Patients with capable of dialysis therapy using the type IIa hollow-fiber dialyzer. 3)Patients with capable of obtaining blood flow rate >= 200 mL/min. 4)Patients who are capable to participate in the study as outpatients. 5)Patients capable of understanding the informed consent form. 6)Patients >= 20 years and <85 years of age at the time of informed consent.
Key exclusion criteria	1)Patients requiring another blood purification therapy such as peritoneal dialysis other than hemodiafiltration within this study period. 2)Patients with a medical history of anaphylaxis symptoms caused by polysulfone or polyvinylpyrrolidone (PVP). 3)Patients with a medical history of anaphylaxis symptoms caused by vitamin E-coated membrane. 4)Patients in the opinion of the principal investigator to disqualify from participation.
Target sample size	10

Research contact person
Name of lead principal investigator	Kazue Ueki
Organization	Toho Hospital, Sanshikai Medical Corporation
Division name	Kidney dialysis center
Address	1155 Azami Kasakake-cho, Midori-city, Gunma
TEL	0277-76-6311
Email	kueki@toho-hp.jp

Public contact
Name of contact person	Masaki Matsumura
Organization	Toho Hospital, Sanshikai Medical Corporation
Division name	Kidney dialysis center
Address	1155 Azami Kasakake-cho, Midori-city, Gunma
TEL	0277-76-6311
Homepage URL
Email	me6341mm@toho-hp.jp

Sponsor
Institute	Toho Hospital, Sanshikai Medical Corporation
Institute
Department

Funding Source
Organization	ASAHI KASEI MEDICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 30 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date	2018 Year 03 Month 17 Day
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

Management information
Registered date	2018 Year 01 Month 25 Day
Last modified on	2018 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035385