UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030993 |
|---|---|
| Receipt number | R000035385 |
| Scientific Title | Performance comparison of hollow-fiber dialyzers, VPS-VA and VPS-HA |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2018/03/22 17:09:44 |
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Basic information
Public title
Performance comparison of hollow-fiber dialyzers, VPS-VA and VPS-HA
Acronym
Clinical Study of VPS-VA
Scientific Title
Performance comparison of hollow-fiber dialyzers, VPS-VA and VPS-HA
Scientific Title:Acronym
Clinical Study of VPS-VA
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
(End Stage Renal Disease)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the beta 2-microglobulin clearance of VPS-VA is higher than that of VPS-HA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Beta 2-microglobulin clearance
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
Dialysis therapy using VPS-HA for a week.
Hollow-fiber dialyzers will be changed from VPS-HA to VPS-VA.
Dialysis therapy using VPS-VA for two 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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients on stable maintenance dialysis therapy using VPS-HA at least three months.
2)Patients with capable of dialysis therapy using the type IIa hollow-fiber dialyzer.
3)Patients with capable of obtaining blood flow rate >= 200 mL/min.
4)Patients who are capable to participate in the study as outpatients.
5)Patients capable of understanding the informed consent form.
6)Patients >= 20 years and <85 years of age 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 a medical history of anaphylaxis symptoms caused by vitamin E-coated membrane.
4)Patients in the opinion of the principal investigator to disqualify from participation.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazue Ueki |
Organization
Toho Hospital, Sanshikai Medical Corporation
Division name
Kidney dialysis center
Zip code
Address
1155 Azami Kasakake-cho, Midori-city, Gunma
TEL
0277-76-6311
kueki@toho-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Matsumura |
Organization
Toho Hospital, Sanshikai Medical Corporation
Division name
Kidney dialysis center
Zip code
Address
1155 Azami Kasakake-cho, Midori-city, Gunma
TEL
0277-76-6311
Homepage URL
me6341mm@toho-hp.jp
Sponsor or person
Institute
Toho Hospital, Sanshikai Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
ASAHI KASEI MEDICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2018 | Year | 01 | Month | 31 | 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
| 2018 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 25 | Day |
Last modified on
| 2018 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035385
