UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study for FS-501 (hollow fiber dialyzer)
Title of the study (Brief title)	A clinical study for FS-501 (hollow fiber dialyzer)
Region	Japan

Condition
Condition	Renal failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of the FS-501 hollow fiber dialyzer (FS-501BG or FS-501BK) when used for renal failure patients.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Adverse events(from the first investigational device use to right before using the other approved hemodialyzer or hemodiafilter) 2)Device problems (from the day of investigational devices receipt to the day of Investigational devices return) 3)Blood compatibility (change of a white blood-cell count and platelets count during the hemodialysis) (Once on any given day in two weeks of hemodialysis)
Key secondary outcomes	1) Vital signs (blood pressure and heart rate) 2) Clinical laboratory test results

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Dialyze using FS-501 (FS-501BG or FS-501BK) 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patient who signed informed consent form to participate in this study. 2) Patient who is 20 years of age or more and under 80 years at first consent with this study. 3) Renal failure patient under hemodialysis or hemodiafiltration stably for three times per week and 3 to 6 hours per session for more than a half year.
Key exclusion criteria	1) Patient who is pregnant, suspected to be pregnant, or lactating. 2) Patient who has been judged to be unable to participate in this study by the investigator for unstable heart or hemodynamics. 3) Patient who has a severe anemias, severe cardiovascular complications, or arteriosclerosis obliterans 4) Patient has a history of allergy to extracorporeal circulation therapy. 5) Patient who received hemodiafiltration within two weeks before enrollment. 6) Patient who has participated in another drug or medical device clinical study in one month before consent. 7)Patient who has been judged to be unsuitable for participation in the study by the investigator for any other reason.
Target sample size	28

Research contact person
Name of lead principal investigator	Ken Matsugi
Organization	Toray Industries,Inc.
Division name	Medical Devices Clinical Research Dept.
Address	1-1,Nihonbashi-muromachi 2-chome,Chuo-ku,Tokyo 103-8666, JAPAN
TEL	03-3245-8593
Email	Takeshi_Matsugi@nts.toray.co.jp

Public contact
Name of contact person	Takeshi Matsugi
Organization	Toray Industries,Inc.
Division name	Medical Devices Clinical Research Dept.
Address	1-1,Nihonbashi-muromachi 2-chome,Chuo-ku,Tokyo 103-8666, JAPAN
TEL	03-3245-8593
Homepage URL
Email	Takeshi_Matsugi@nts.toray.co.jp

Sponsor
Institute	Toray Industries, Inc.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2015 Year 11 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 25 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2016 Year 02 Month 19 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	2015 Year 11 Month 18 Day
Last modified on	2016 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022936