UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of the performance and safety on hollow fiber type dialyzer "APS-MA".
Title of the study (Brief title)	Clinical evaluation of APS-MA
Region	Japan

Condition
Condition	Chronic Kidney Failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the performance, blood compatibility and safety of APS-21MA compared with APS-21MDNew.
Basic objectives2	Others
Basic objectives -Others	Peformance, Safety
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Clearance 2) Reduction rate 3) Removal amount 4) Albumin leakage 5) Blood compatibility (Fluctuations in the number of white blood cells and platelets during hemodialysis) 6) Antithrombotic property
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Hemodialysis using APS-MA and APS-MDNew for 2 weeks each
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	1)Maintenance dialysis patients corresponding to - three times per week - more than three and a half hours in each dialysis session - hemodialysis for more than six months 2)Qb 200 mL/min is possible when the evaluation. 3)Outpatients. 4)Ability to give written informed consent. 5)Aged 20 to <80 years at the time of informed consent.
Key exclusion criteria	1)Need to blood purification other than hemodialysis. 2)Judged ineligible by the attending physician.
Target sample size	6

Research contact person
Name of lead principal investigator	Yoshihiko Nakajima
Organization	Rokko Island Konan Hospital
Division name	Blood purification Center
Address	2-11 Koyo-cho Naka, Higashinada-ku, Kobe
TEL	078-858-1111
Email	ro_jinkoujinzoubu@kohnan.or.jp

Public contact
Name of contact person	Hiroko Haibara
Organization	Rokko Island Konan Hospital
Division name	Medical Engineering Center
Address	2-11 Koyo-cho Naka, Higashinada-ku, Kobe
TEL	078-858-1111
Homepage URL
Email	ro_jinkoujinzoubu@kohnan.or.jp

Sponsor
Institute	Rokko Island Konan Hospital
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	2017 Year 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 31 Day
Anticipated trial start date	2017 Year 05 Month 08 Day
Last follow-up date	2017 Year 07 Month 08 Day
Date of closure to data entry	2017 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 26 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=R000031100