UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029203 |
|---|---|
| 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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public 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)
Acronym
Clinical research to develop the new Qs control program
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)
Scientific Title:Acronym
Clinical research to develop the new Qs control program
Region
| Japan |
Condition
Condition
Chronic Kidney Failure
(End Stage Renal Disease)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Others
Basic objectives -Others
Performance and safety of the dialysis machine JMS GC-X01 and hemodiafilter ABH-22PA
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of albumin leakage
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
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Hemodiafiltration therapy using JMS GC-X01 dialysis machine and hemodiafilter ABH-22PA for 8 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)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.
Key exclusion criteria
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.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Sato |
Organization
Kaikoukai Medical Foundation
Division name
Meiko Kyoritsu Clinic
Zip code
Address
8-202 Kiba-cho, Minato-ku, Nagoya city, Aichi
TEL
052-698-3077
t-sato@kaikou.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Taoka |
Organization
Kaikoukai Medical Foundation
Division name
Meiko Kyoritsu Clinic
Zip code
Address
8-202 Kiba-cho, Minato-ku, Nagoya city, Aichi
TEL
052-698-3077
Homepage URL
m-taoka@kaikou.or.jp
Sponsor or person
Institute
Kaikoukai Medical Foundation
Meiko Kyoritsu Clinic
Institute
Department
Personal name
Funding Source
Organization
ASAHI KASEI MEDICAL CO., LTD.
JMS Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2017 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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)
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
| 2017 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 12 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 19 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 20 | Day |
Last modified on
| 2018 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033381
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
