UMIN-CTR Clinical Trial

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
Email	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
Email	michiwaki@khg.or.jp

Sponsor
Institute	Social medical corporation Kawashimakai
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051534