UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029035 |
|---|---|
| Receipt number | R000033200 |
| Scientific Title | Evaluation of the removal performance of ABH-22PA when it is used at post-dilution online hemodiafiltration under various dialysis conditions |
| Date of disclosure of the study information | 2017/09/07 |
| Last modified on | 2018/03/22 16:53:54 |
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Basic information
Public title
Evaluation of the removal performance of ABH-22PA when it is used at post-dilution online hemodiafiltration under various dialysis conditions
Acronym
Evaluation of removal performance of ABH-PA at post-dilution online hemodiafiltration
Scientific Title
Evaluation of the removal performance of ABH-22PA when it is used at post-dilution online hemodiafiltration under various dialysis conditions
Scientific Title:Acronym
Evaluation of removal performance of ABH-PA at post-dilution online hemodiafiltration
Region
| Japan |
Condition
Condition
Chronic Kidney Failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the removal performance of ABH-22PA when it is used at post-dilution online HDF setting various QB and Qs. In addition, confirm that post-dilution online HDF using ABH-22PA can be performed safety regardless of Qs.
Basic objectives2
Others
Basic objectives -Others
Performance, safety
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Reduction rate
2) Removal amount
3) Albumin leakage
4) Transmembrane pressure and Number of alarms
5) Antithrombotic property
6) Adverse events and Device deficiencies
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
Hemodiafiltration using ABH-22PA for 6 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 who have received hemodiafiltraion using ABH-P or ABH-PA for more than one month at the time of informed consent.
2)Qb 300 mL/min is possible.
3)Outpatients.
4)Ability to understand this research and to give written informed consent.
5)Aged 20 to <80 years at the time of informed consent.
Key exclusion criteria
1)Need to blood purification other than hemodiafiltraion.
2)With a medical history of anaphylaxis symptoms caused by polysulfone or polyvinylpyrrolidone (PVP).
3)Patients who will participate in other clinical trial during this research.
4)Judged ineligible by the attending physician.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Minakuchi |
Organization
Kawashima Hospital
Division name
Division of Nephrology, Endocrinology
Zip code
Address
1-39 Kitasako Ichiban-cho, Tokushima, Tokushima
TEL
088-631-0110
minakuchi_j@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Fujiwara |
Organization
Wakimachi Kawashima Clinic
Division name
Division of clinical engineering
Zip code
Address
39-2 Wakimachi Oaza Inoshiritatejinjashimominami, Mima, Tokushima
TEL
0883-55-0110
Homepage URL
we563@hotmail.co.jp
Sponsor or person
Institute
Wakimachi Kawashima Clinic
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
| 2017 | Year | 09 | Month | 07 | 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
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 | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 07 | 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=R000033200
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
