Unique ID issued by UMIN | UMIN000018858 |
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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 |
A clinical study for FS-311(hemodiafilter)
A clinical study for FS-311(hemodiafilter)
A clinical study for FS-311(hemodiafilter)
A clinical study for FS-311(hemodiafilter)
Japan |
Renal failure
Nephrology |
Others
NO
The purpose of this study is to collect safety and effectiveness date evaluating FS-311 (hemodiafilter) when used to renal failure patients.
Safety,Efficacy
1)adverse events
2)Device deficiencies
3)blood compatibility(change of a white blood-cell count and platelets count during the HDF session)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Hemodiafiltration using FS-311 for 2 weeks
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
14
1st name | |
Middle name | |
Last name | Takeshi Matsugi |
Toray Industries,Inc.
Medical Devices Clinical Research Dept.
1-1, Nihonbashi-muromachi 2-chome,Chuo-ku,Tokyo 103-8666,JAPAN
03-3245-8593
Takeshi_Matsugi@nts.toray.co.jp
1st name | |
Middle name | |
Last name | Takeshi Matsugi |
Toray Industries,Inc.
Medical Devices Clinical Research Dept.
1-1, Nihonbashi-muromachi 2-chome,Chuo-ku,Tokyo 103-8666,JAPAN
03-3245-8593
Takeshi_Matsugi@nts.toray.co.jp
Toray Industries,Inc.
None
Self funding
NO
2015 | Year | 09 | Month | 01 | Day |
Unpublished
Completed
2015 | Year | 06 | Month | 09 | Day |
2015 | Year | 08 | Month | 17 | Day |
2015 | Year | 09 | Month | 22 | Day |
2015 | Year | 08 | Month | 31 | Day |
2015 | Year | 12 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021797
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