Renal failure
Conditions
Interventions
Dialyze using FS-501 (FS-501BG or FS-501BK) for two weeks.
Sponsors
Toray Industries, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Vital signs (blood pressure and heart rate) 2) Clinical laboratory test results | — |
Countries
Japan
Contacts
Public ContactTakeshi Matsugi
Toray Industries,Inc. Medical Devices Clinical Research Dept.
Outcome results
None listed