Unique ID issued by UMIN | UMIN000029203 |
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Receipt number | R000033381 |
Scientific Title | Development of a new method to control albumin leakage during on-line hemodiafiltration (HDF) therapies for maintenance dialysis patients (New Qs control program of JMS GC-X01 dialysis machine using hemodiafilter ABH-22PA) |
Date of disclosure of the study information | 2017/09/20 |
Last modified on | 2018/05/22 11:35:44 |
Development of a new method to control albumin leakage during on-line hemodiafiltration (HDF) therapies for maintenance dialysis patients (New Qs control program of JMS GC-X01 dialysis machine using hemodiafilter ABH-22PA)
Clinical research to develop the new Qs control program
Development of a new method to control albumin leakage during on-line hemodiafiltration (HDF) therapies for maintenance dialysis patients (New Qs control program of JMS GC-X01 dialysis machine using hemodiafilter ABH-22PA)
Clinical research to develop the new Qs control program
Japan |
Chronic Kidney Failure
(End Stage Renal Disease)
Nephrology |
Others
NO
To develop a new Qs control program (to regulate amount of albumin leakage) for JMS GC-X01 dialysis machine using hemodiafilter ABH-22PA, and to evaluate the validity of the new program installed in the GC-X01.
Others
Performance and safety of the dialysis machine JMS GC-X01 and hemodiafilter ABH-22PA
Confirmatory
Pragmatic
Not applicable
Amount of albumin leakage
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
1
Treatment
Device,equipment |
Hemodiafiltration therapy using JMS GC-X01 dialysis machine and hemodiafilter ABH-22PA for 8 weeks.
20 | years-old | <= |
80 | years-old | > |
Male and Female
1)Patients on stable maintenance hemodialysis therapy at least one month on a 3 times per a week schedule with not less than 4 hours per a treatment.
2)Patients corresponding to the following at the time of registration
- Total protein: 5.0 - 7.0 g/dL
- Hematocrit: 28 - 38%.
3)Patients with capable of obtaining blood flow rate >250 mL/min.
4)Patients who are capable to participate in the study as outpatients.
5)Patients capable of understanding the informed consent form.
6)Aged 20 to <80 years at the time of informed consent.
1)Patients requiring another blood purification therapy such as peritoneal dialysis other than hemodiafiltration within this study period.
2)Patients with a medical history of anaphylaxis symptoms caused by polysulfone or polyvinylpyrrolidone (PVP).
3)Patients with hypoalbuminemia.
4)Female patients who are or have possibility of pregnant, or breast feeding.
5)Patients who have a history of liver, heart, or lung diseases (ex. Decompensated cirrhosis).
6)Patients with previously untreated malignant tumors.
7)Patients with dementia.
8)Patients having a plan of participating in any other clinical trial within this study period.
9)Patients in the opinion of the principal investigator to disqualify from participation.
5
1st name | |
Middle name | |
Last name | Takashi Sato |
Kaikoukai Medical Foundation
Meiko Kyoritsu Clinic
8-202 Kiba-cho, Minato-ku, Nagoya city, Aichi
052-698-3077
t-sato@kaikou.or.jp
1st name | |
Middle name | |
Last name | Masahiro Taoka |
Kaikoukai Medical Foundation
Meiko Kyoritsu Clinic
8-202 Kiba-cho, Minato-ku, Nagoya city, Aichi
052-698-3077
m-taoka@kaikou.or.jp
Kaikoukai Medical Foundation
Meiko Kyoritsu Clinic
ASAHI KASEI MEDICAL CO., LTD.
JMS Co., Ltd.
Profit organization
Japan
NO
2017 | Year | 09 | Month | 20 | Day |
Published
Amount of albumin leakage
2points TMP control
Low (target 2g) 3.58g +/- 0.37g(CV:0.103)
Middle(target 4g) 5.58g +/- 1.54g(CV:0.277)
High (target 6g) 6.83g +/- 2.67g(CV:0.391)
3points TMP control
Low (target 2g) 2.96g +/- 0.68g(CV:0.229)
Middle(target 4g) 6.30g +/- 1.17g(CV:0.186)
High (target 6g) 7.81g +/- 3.07g(CV:0.393)
Completed
2017 | Year | 07 | Month | 06 | Day |
2017 | Year | 09 | Month | 20 | Day |
2018 | Year | 01 | Month | 05 | Day |
2018 | Year | 01 | Month | 12 | Day |
2018 | Year | 01 | Month | 19 | Day |
2018 | Year | 01 | Month | 26 | Day |
2017 | Year | 09 | Month | 20 | Day |
2018 | Year | 05 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033381
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