UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023402 |
|---|---|
| Receipt number | R000026958 |
| Scientific Title | Removal of protein-bound uremic toxins by acetate-free biofiltraition in dialysis patients |
| Date of disclosure of the study information | 2016/07/29 |
| Last modified on | 2022/08/03 09:19:05 |
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Basic information
Public title
Removal of protein-bound uremic toxins by acetate-free biofiltraition in dialysis patients
Acronym
AFBF and uremic toxins
Scientific Title
Removal of protein-bound uremic toxins by acetate-free biofiltraition in dialysis patients
Scientific Title:Acronym
AFBF and uremic toxins
Region
| Japan |
Condition
Condition
End-stage kidney disease patients undergoing dialysis treatment
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand whether acetate-free biofiltration removes more protein-bound uremic toxins than regular hemodialysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of serum uremic toxins level
Key secondary outcomes
Removal of uremic toxins with hemodialyzer
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing maintenance hemodialysis
Key exclusion criteria
Patients who do not agree informed consent.
Patients who have hospitalization owing to cardiovascular disease, malignancy and infectious disease during 6 months.
Pregnant women
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Blood Purification Therapy
Zip code
951-8520
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL
025-227-2200
yamamots@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Blood Purification Therapy
Zip code
951-8520
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL
025-227-2200
Homepage URL
yamamots@med.niigata-u.ac.jp
Sponsor or person
Institute
Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Science, 1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
Institute
Department
Personal name
Funding Source
Organization
Niigata University Medical and Dental Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Medical and Dental Hospital
Address
1-757 Asahimachi-dori, Niigata 951-8510
Tel
0252272200
ethics@adm.niigata-u.ac.jp
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
| 2016 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
20
Results
Use of acetate-free biofiltration method did not increase the removal of uremic toxins in end-stage kidney disease patients.
Results date posted
| 2021 | Year | 08 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
End-stage kidney disease patients undergoing regular hemodialysis, hemodiafiltration and hemodialysis using acetate-free biofiltration method.
Participant flow
Those patients joined this study.
Adverse events
NA
Outcome measures
Serum levels of several uremic toxins.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2016 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of serum uremic toxins level in before/after treatment as well as before/after passing the column between acetate-free biofiltration and regular hemodialysis treatment.
Management information
Registered date
| 2016 | Year | 07 | Month | 29 | Day |
Last modified on
| 2022 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026958
| 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 |
