UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053304 |
|---|---|
| Receipt number | R000060841 |
| Scientific Title | Retrospective clinical study for the involvement of protein-energy wasting and inflammation in the impact of serum albumin concentration and albumin leakage on survival in patients on super high flux hemodialysis, super high flux-albumin-leaking hemodialysis, and online hemodiafiltration |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2025/01/10 09:39:46 |
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Basic information
Public title
Research on the involvement of protein-energy wasting and inflammation in the impact of serum albumin concentration and albumin leakage on survival in dialysis patients
Acronym
Prognostic verification of PEW, inflammation, serum albumin concentration, and albumin leakage in dialysis patients
Scientific Title
Retrospective clinical study for the involvement of protein-energy wasting and inflammation in the impact of serum albumin concentration and albumin leakage on survival in patients on super high flux hemodialysis, super high flux-albumin-leaking hemodialysis, and online hemodiafiltration
Scientific Title:Acronym
Prognosis verification of PEW, inflammation, serum albumin concentration, and albumin leakage in patients with SHF-HD, SHF-albumin-leaking-HD, and OHDF
Region
| Japan |
Condition
Condition
Patients with end-stage kidney disease undergoing hemodialysis using dialyzers with beta2-microglobulin clearance of more than 70 mL/min and online hemodiafiltration
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We clarify the involvement of protein-energy wasting and inflammation in the impact of serum albumin concentration and albumin leakage on 3-year all-cause mortality in hemodialysis and online hemodiafiltration using beta2-microglobulin clearance of 70 mL/min and more
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-year all-cause mortality
1) High serum albumin concentration group vs. low serum albumin concentration group by median value
2) High albumin leakage group vs. low albumin leakage group by median value
3) High serum albumin concentration and high albumin leakage group vs.
(1) Low serum albumin concentration and high albumin leakage group by median value
(2) High serum albumin concentration and low albumin leakage group by median value
(3) Low serum albumin concentration and low albumin leakage group by median value
Key secondary outcomes
3-year all-cause mortality
1) High serum albumin concentration group vs. low serum albumin concentration group by median value
2) High albumin leakage group vs. low albumin leakage group by median value
3) High serum albumin concentration and high albumin leakage group vs.
(1) Low serum albumin concentration and high albumin leakage group by median value
(2) High serum albumin concentration and low albumin leakage group by median value
(3) Low serum albumin concentration and low albumin leakage group by median value
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 on maintenance hemodialysis or online hemodialysis as of July 1, 2017
Key exclusion criteria
1 Use of dialyzers with beta2-microgloburln clearance below 70 mL/min
2 Missing data for covariates at study entry
3 Dialysis conditionssuch as dialysis method and membrane material between April 1, 2017 and June 30, 2017, which are different from those as of July 1, 2017
4 Blood purification methods other than HD
5 Dialysis frequency below 3 sessions per week or dialysis time below 3 hour per session
6 Pregnant or lactating patients
Target sample size
700
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
770-0011
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima, Japan
TEL
+81886310110
kokada@minos.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Okada |
Organization
Social medical corporation, Kawashimakai, Kawashima hospital
Division name
Department of Nephrology
Zip code
770-0011
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima, Japan
TEL
088-631-0110
Homepage URL
m.tashiro@khg.or.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Others
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, Japan
Tel
+81886310110
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
| 2024 | Year | 12 | 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 | 01 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We have reported that mortality is not significantly different between Japanese-style predilution online hemodiafiltration and postdilution online hemodiafiltration using a propensity score-matched model. We have then reported that mortality on high albumin leakage group is reduced more than that on low albumin leakage group, that high albumin leakage with low serum albumin concentration group does not necessarily worsen survival as compared to high albumin leakage and high serum albumin concentration group in both hemodialysis and online hemodiafiltration, and that the mortality is equivalent between these modalities with a similar level of serum albumin concentration and albumin leakage. We have also demonstrated that mortality is improved when dialyzers with albumin leakage was >3 g/session compared to <3 g/session in HD using dialyzers with beta2-microglobulin clearance >70 mL/min. In 2023, the Japanese Society for Dialysis Therapy has published in an academic journal that for dialyzer membranes with beta2-microglobulin clearance >70mL/min will be expressed as super high flux, and sieving coefficient for albumin >0.03 will be expressed as SHF albumin-leaking.
Because protein-energy wasting and inflammation are decreasing hepatic albumin synthesis, The aim of this study was to investigate whether or not serum albumin concentration and albumin leakage determine survival and to evaluate a correlation between serum albumin concentration and albumin leakage depending on the absence and presence of protein-energy wasting and inflammation in patients on super high flux hemodialysis, super high flux albumin-leaking hemodialysis, and online hemodiafiltration.
Management information
Registered date
| 2024 | Year | 01 | Month | 10 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060841
