UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019853 |
|---|---|
| Receipt number | 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 16:43:59 |
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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
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
Takeshi_Matsugi@nts.toray.co.jp
Sponsor or person
Institute
Toray Industries, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022936
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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