UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective clinical study for albumin leakage and survival between hemodialysis and online hemodiafiltration
Acronym	Prognosis verification albumin leakage between super high-flux HD and OHDF
Scientific Title	Retrospective clinical study to compare survival between super high-flux hemodialysis with high albumin leakage and online hemodiafiltration with low albumin leakage
Scientific Title:Acronym	Prognosis verification of super high-flux hemodialysis with high albumin leakage and online hemodiafiltration with low albumin leakage
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 3-year all-cause mortality in super high-flux HD with high albumin lealage and OHDF with low albumin leakage
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	3-year all-cause mortality during 3 yearss between super high-flux HD with high albumin leakage and OHDF with low albumin leakage
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 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 including 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 predilution OHDF and less than 8 L in postdilution OHDF 6 Pregnant or lactating patients 7 Missing values of variables at the start of the study 8 Beta2 microglobulin clearance less than 70 mL per min
Target sample size	800

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 Manabu Middle name Last name Tashiro
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
Email	m.tashiro@khg.or.jp

Sponsor
Institute	Kawashima hospital
Institute
Department

Funding Source
Organization	Kawashima 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	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 10 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
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	2022 Year 02 Month 15 Day
Date of IRB	2022 Year 04 Month 12 Day
Anticipated trial start date	2022 Year 07 Month 06 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing

Management information
Registered date	2022 Year 06 Month 04 Day
Last modified on	2022 Year 12 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054664