UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019853
Receipt No. R000022936
Scientific Title A clinical study for FS-501 (hollow fiber dialyzer)
Date of disclosure of the study information 2015/11/26
Last modified on 2016/05/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A clinical study for FS-501 (hollow fiber dialyzer)
Acronym A clinical study for FS-501 (hollow fiber dialyzer)
Scientific Title A clinical study for FS-501 (hollow fiber dialyzer)
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Ken Matsugi
Organization Toray Industries,Inc.
Division name Medical Devices Clinical Research Dept.
Zip code
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
1st name
Middle name
Last name Takeshi Matsugi
Organization Toray Industries,Inc.
Division name Medical Devices Clinical Research Dept.
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 08 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.