UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045112 |
|---|---|
| Receipt number | R000051534 |
| Scientific Title | Retrospective clinical study for albumin leakage and survival in hemodialysis and online hemodiafiltration |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2022/01/04 15:51:00 |
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Basic information
Public title
Retrospective clinical study for albumin leakage and survival in hemodialysis and online hemodiafiltration
Acronym
Prognosis verification of albumin leakage in HD and OHDF
Scientific Title
Retrospective clinical study for albumin leakage and survival in hemodialysis and online hemodiafiltration
Scientific Title:Acronym
Prognosis verification of albumin leakage in HD and OHDF
Region
| Japan |
Condition
Condition
Patients with end-stage renal failure undergoing hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We clarify the relationship between albumin leakage and all-cause mortality during 3 years in HD and OHDF
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of all-cause mortality during 3 yearss for estimated albumin leakage (high vs. low) in HD and OHDF
Key secondary outcomes
1. Comparison of all-cause mortality during 3 years in groups divided by estimated albumin leakage (high and low) and serum albumin concentration (high and low) in HD and OHDF
2. Direct comparison of HD and OHDF on all-cause mortality during 3 years divided by the same ranges of estimated albumin leakage (less than 2.5g, 2.5g or more and less than 5.0g, 5.0g or more and less than 7.5g)
3. Direct comparison of estimated albumin leakage and the substitution volume in pre-OHDF and post-OHDF on all-cause mortality during 3 years
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 hemodiafiltration 3 times a week as of July 1, 2017
Key exclusion criteria
1) Under 20 years of age
2) Dialysis conditions (dialysis method, dilution method, substitution volume, membrane material) between April 1, 2017 and June 30, 2017, which are different from those as of July 1, 2017
3) Blood purification methods other than HD or OHDF
4) Dialysis frequency below 3 sessions per week or dialysis time below 3 hour per session
5) Substitution volume of less than 60 L in pre-OHDF and less than 8 L in post-OHDF
6) Pregnant or lactating patients
7) Missing values of covariatesat at the start of the study
Target sample size
780
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Okada |
Organization
Social medical corporation Kawashimakai
Division name
Blood purification management center
Zip code
770-0011
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima,Japan
TEL
088-631-0110
kokada@minos.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Michiwaki |
Organization
Social medical corporation, Kawashimakai, Kawashima hospital
Division name
Department of Clinical Engineering
Zip code
770-0011
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima,Japan
TEL
088-631-0110
Homepage URL
michiwaki@khg.or.jp
Sponsor or person
Institute
Social medical corporation Kawashimakai
Institute
Department
Personal name
Funding Source
Organization
Social medical corporation Kawashimakai
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
088-631-0110
kokada@minos.ocn.ne.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
| 2022 | Year | 01 | Month | 01 | 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
780
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
| 2021 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2021 | Year | 08 | Month | 10 | Day |
Last modified on
| 2022 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051534
