UMIN-CTR Clinical Trial

Basic information
Public title	Comparison between online pre-dilution and online post-dilution hemodiafiltration.
Acronym	Comparison between pre-dilution and post-dilution hemodiafiltration.
Scientific Title	Comparison between online pre-dilution and online post-dilution hemodiafiltration.
Scientific Title:Acronym	Comparison between pre-dilution and post-dilution hemodiafiltration.
Region	Japan

Condition
Condition	Chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Removal characteristics of solutes and safety are compared between pre-HDF and post-HDF.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Removal performances for solutes including BUN, beta2-MG and alpha1-MG, and amount of albumin loss.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	48L pre-dilution HDF(three times in a week, 2weeks) 8L post-dilution OHDF(2weeks) Convection volume 10L post-dilution HDF(2weeks)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients who have been receiving online HDF. 2)Serum albumin concentration will be more than 3.3 g/dL. 3)Patients who will have stable arteriovenous fistula that can get more than 200 mL/min blood flow. 4)Hemodynamics will be stable. 5)Dialysis vintage will be more than 2 years.
Key exclusion criteria	None
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Fukuchi
Organization	ASAMA General Hospital
Division name	Medical department
Zip code	385-0022
Address	1862-1 Iwamurata, Saku-shi, Nagano
TEL	0267-67-2295
Email	satoshi-f@hi.enjoy.ne.jp

Public contact
Name of contact person	1st name Shuji Middle name Last name Takahashi
Organization	ASAMA General Hospital
Division name	Clinical engineering department
Zip code	385-0022
Address	1862-1 Iwamurata, Saku-shi, Nagano
TEL	0267-67-2295
Homepage URL
Email	h-rinsho@city.saku.nagano.jp

Sponsor
Institute	ASAMA General Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical review board of Asama General Hospital
Address	1862-1 Iwamurata, Saku-shi, Nagano
Tel	0267-67-2295
Email	asama-soumu@city.saku.nagano.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	2021 Year 06 Month 20 Day

Related information
URL releasing protocol	https://www.umin.ac.jp/ctr/UMIN-CTR_Yougo.htm The information except the description in this site is
Publication of results	Partially published

Result
URL related to results and publications	https://www.umin.ac.jp/ctr/UMIN-CTR_Yougo.htm The information except the description in this site is
Number of participants that the trial has enrolled	6
Results	The 25th annual meeting of Japanese Society for hemodiafiltration Results in patients treated with 2.1m2 filter (beta2-MG reduction rate, alpha1-MG reduction rate, Alb loss) 48L pre-dilution HDF:79.1%, 21.0%, 3.1g 8L post-dilution HDF:78.7%, 29.2%, 4.3g Convection volume 10L post-dilution HDF:77.2%, 23.9%, 3.8g Results in patients treated with 2.6m2 filter 48L pre-dilution HDF:4.1%, 20.0%, 3.6g 8L post-dilution HDF:74.9%, 31.0%, 5.8g Convection volume 10L post-dilution HDF:73.0%, 21.3%, 3.7g
Results date posted	2021 Year 06 Month 16 Day
Results Delayed	Delay expected
Results Delay Reason	To prepare the paper submission
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events	None
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 08 Month 01 Day
Date of IRB	2018 Year 09 Month 21 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2019 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 06 Month 16 Day
Last modified on	2021 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050909