UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055718 |
|---|---|
| Receipt number | R000063229 |
| Scientific Title | Cross-sectional study about factors influencing alfa1-microglobulin removal ratio in patients on predilution online hemodiafiltration |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/04/07 16:52:55 |
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Basic information
Public title
Study about factors influencing alfa1-microglobulin removal ratio in patients on online hemodiafiltration
Acronym
Study about factors influencing alfa1-microglobulin removal ratio in online hemodiafiltration
Scientific Title
Cross-sectional study about factors influencing alfa1-microglobulin removal ratio in patients on predilution online hemodiafiltration
Scientific Title:Acronym
Cross-sectional study about factors influencing alfa1-microglobulin removal ratio in pre-OHDF
Region
| Japan |
Condition
Condition
Patients with end-stage kidney disease undergoing predilution online hemodiafiltration
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We clarify factors correlated with alfa1-microglobulin removal ratio in predilution online hemodiafiltration
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Significant factors associated with alfa1-MG removal ratio (univariate analysis and multivariate analysis)
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent predilution online hemodialysis using a dialysis machine (TPM 3-point method) as of July 1, 2023
Key exclusion criteria
1 Missing data for covariates at study entry
2 Implemented less than 3 months ago as of July 1, 2023
3 Blood purification methods other than OHDF
4 Dialysis frequency below 3 sessions per week or dialysis time below 3 hour per session
5 Substitution volume less than 60L
6 Alfa1-microglobulin removal ratio is negative
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Okada |
Organization
Social medical corporation Kawashimakai Kawashima Hospital
Division name
Blood purification management center
Zip code
7700011
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima
TEL
088-631-0110
kokada@minos.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Tashiro |
Organization
Social medical corporation Kawashimakai Kawashima Hospital
Division name
Department of Nephrology
Zip code
7700011
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima
TEL
088-631-0110
Homepage URL
m.tashiro@khg.or.jp
Sponsor or person
Institute
Social medical corporation Kawashimakai Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Social medical corporation Kawashimakai Kawashima Hospital
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima
Tel
088-631-0110
m.tashiro@khg.or.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
| 2025 | Year | 03 | 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
| 2024 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Increasing the removal ratio of alfa1-microglobulin may improve life prognosis. This study clarifies factors for increasing the removal ratio of alfa1-microglobulin.
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063229
