UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018858 |
|---|---|
| Receipt number | R000021797 |
| Scientific Title | A clinical study for FS-311(hemodiafilter) |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2015/12/03 11:01:04 |
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Basic information
Public title
A clinical study for FS-311(hemodiafilter)
Acronym
A clinical study for FS-311(hemodiafilter)
Scientific Title
A clinical study for FS-311(hemodiafilter)
Scientific Title:Acronym
A clinical study for FS-311(hemodiafilter)
Region
| Japan |
Condition
Condition
Renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to collect safety and effectiveness date evaluating FS-311 (hemodiafilter) when used to renal failure patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)adverse events
2)Device deficiencies
3)blood compatibility(change of a white blood-cell count and platelets count during the HDF session)
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
Hemodiafiltration using FS-311 for 2 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)Renal failure patients under hemodiafitration or hemodialysis three times per week and 3 to 6 hours per session for more than a half year
2)Patients under hemodiafiltration for more than recent 2 weeks
Key exclusion criteria
1)Patients who are pregnant or suspected to be pregnant, patients who are breast-feeding
2)Patients who are judged to be unable to attend this study as cardiovascular diseases by the investigator
3)Patients who have severe anemias or severe cardiovascular complications, patients who have severe arteriosclerosis obliterans
4)Patients with a history of allergy against extracorporeal circulation therapy
5)Other patients who are considerd ineligible for this study by the investigator
Target sample size
14
Research contact person
Name of lead principal investigator
| 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
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 | 09 | Month | 01 | 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 | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 22 | 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 | 08 | Month | 31 | Day |
Last modified on
| 2015 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021797
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
