UMIN-CTR Clinical Trial

Basic information
Public title	FX-180HDF performance evaluation
Acronym	FX-180HDF performance evaluation
Scientific Title	FX-180HDF performance evaluation
Scientific Title:Acronym	FX-180HDF performance evaluation
Region	Japan

Condition
Condition	End stage renal disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate characteristics of solute removal by hemodiafilter, FX-180HDF, used under high substitution.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Concentrations of albumin, beta2-MG, alpha1-MG in dialysate drainage
Key secondary outcomes	Convection Volume,Transmennbrane pressure

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	9
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	FX-180HDF, Pre-dilution 48L, under conditions of blood flow (280ml/min)for 1 week
Interventions/Control_2	FX-180HDF, Pre-dilution 60L, under conditions of blood flow (280ml/min)for 1 week
Interventions/Control_3	FX-180HDF, Post-dilution 12L, under conditions of blood flow (280ml/min)for 1 week
Interventions/Control_4	FX-180HDF, Post-dilution 16L, under conditions of blood flow (280ml/min)for 1 week
Interventions/Control_5	FX-180HDF, Pre-dilution 48L, under conditions of blood flow (300ml/min)for 1 week
Interventions/Control_6	FX-180HDF, Pre-dilution 60L, under conditions of blood flow (300ml/min)for 1 week
Interventions/Control_7	FX-180HDF, Post-dilution 12L, under conditions of blood flow (300ml/min)for 1 week
Interventions/Control_8	FX-180HDF, Post-dilution 16L, under conditions of blood flow (300ml/min)for 1 week
Interventions/Control_9	FX-180HDF, Post-dilution 20L, under conditions of blood flow (300ml/min)for 1 week
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Stable maintenance dialysis patients Patients who have no access troubles(occlusion, stenosis, etc.) or puncture difficulties Consent can be obtained from the patient or their representatives.
Key exclusion criteria	When consent from the patient or their representatives is not available for participation in this study. Any other cases that doctors consider inappropriate for participation in this study.
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Asako Middle name Last name Nozaki
Organization	Kawashima Hospital
Division name	Clinical department of engineering
Zip code	7700011
Address	1-1-39 Kitasako, Tokusima, 770-8548, Japan
TEL	088-631-0110
Email	asako.nozaki0@gmail.com

Public contact
Name of contact person	1st name Asako Middle name Last name Nozaki
Organization	Kawashima Hospital
Division name	Clinical department of engineering
Zip code	7700011
Address	1-1-39 Kitasako, Tokusima, 770-8548, Japan
TEL	088-631-0110
Homepage URL
Email	asako.nozaki0@gmail.com

Sponsor
Institute	Kawashima Hospital
Institute
Department

Funding Source
Organization	Kawashima Hospital
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	Kawashima Hospital
Address	1-1-39 Kitasako, Tokusima, 770-8548, Japan
Tel	088-631-0110
Email	asako.nozaki0@gmail.com

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	2019 Year 12 Month 23 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	Preinitiation
Date of protocol fixation	2019 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date	2019 Year 12 Month 23 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 10 Day
Last modified on	2019 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044295