UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027140 |
|---|---|
| Receipt number | R000031100 |
| Scientific Title | Clinical evaluation of the performance and safety on hollow fiber type dialyzer "APS-MA". |
| Date of disclosure of the study information | 2017/04/28 |
| Last modified on | 2018/03/22 16:54:27 |
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Basic information
Public title
Clinical evaluation of the performance and safety on hollow fiber type dialyzer "APS-MA".
Acronym
Clinical evaluation of APS-MA
Scientific Title
Clinical evaluation of the performance and safety on hollow fiber type dialyzer "APS-MA".
Scientific Title:Acronym
Clinical evaluation of APS-MA
Region
| Japan |
Condition
Condition
Chronic Kidney Failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the performance, blood compatibility and safety of APS-21MA compared with APS-21MDNew.
Basic objectives2
Others
Basic objectives -Others
Peformance, Safety
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Clearance
2) Reduction rate
3) Removal amount
4) Albumin leakage
5) Blood compatibility (Fluctuations in the number of white blood cells and platelets during hemodialysis)
6) Antithrombotic property
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Hemodialysis using APS-MA and APS-MDNew for 2 weeks each
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)Maintenance dialysis patients corresponding to
- three times per week
- more than three and a half hours in each dialysis session
- hemodialysis for more than six months
2)Qb 200 mL/min is possible when the evaluation.
3)Outpatients.
4)Ability 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 hemodialysis.
2)Judged ineligible by the attending physician.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Nakajima |
Organization
Rokko Island Konan Hospital
Division name
Blood purification Center
Zip code
Address
2-11 Koyo-cho Naka, Higashinada-ku, Kobe
TEL
078-858-1111
ro_jinkoujinzoubu@kohnan.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Haibara |
Organization
Rokko Island Konan Hospital
Division name
Medical Engineering Center
Zip code
Address
2-11 Koyo-cho Naka, Higashinada-ku, Kobe
TEL
078-858-1111
Homepage URL
ro_jinkoujinzoubu@kohnan.or.jp
Sponsor or person
Institute
Rokko Island Konan Hospital
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 | 04 | Month | 28 | 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 | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 26 | 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=R000031100
