UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to evaluate the clinical effectiveness of intermittent infusion hemodiafiltration (I-HDF)
Title of the study (Brief title)	Study to evaluate the clinical effectiveness of I-HDF
Region	Japan

Condition
Condition	Chronic Kidney Failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the clinical condition and quality of life (QOL) of I-HDF compared with HD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	SF-36 ver2 Clinical condition (VAS scale)
Key secondary outcomes	Vital signs (blood pressure, pulse) Number of treatments by medical staff Blood test Dose of erythropoietin-stimulating agent Solute removal ability

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	HD therapy (for 3 months) --> I-HDF therapy (for 3 months) --> HD therapy (for 3 months)
Interventions/Control_2	I-HDF therapy (for 3 months) --> HD therapy (for 3 months) --> I-HDF therapy (for 3 months)
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Hemodialysis patient who on-line HDF therapy is possible, and can give written informed consent - 18 years and over - Hemodialysis for more than 6 months
Key exclusion criteria	1) Patients with severe cardiovascular disease (NYHA class 3 or 4), hepatic failure, respiratory failure, or malignant tumor 2) 8% or more of the rate of weight gain 3) Patients who are judged ineligible by the attending physician.
Target sample size	70

Research contact person
Name of lead principal investigator	Michio Mineshima
Organization	Tokyo Women's Medical University
Division name	Department of Clinical Engineering
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	mmine@twmu.ac.jp

Public contact
Name of contact person	Ryoichi Sakiyama
Organization	Tokyo Women's Medical University
Division name	Department of Clinical Engineering
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	sakiyama@twmu.ac.jp

Sponsor
Institute	I-HDF Multicenter Study Group
Institute
Department

Funding Source
Organization	JMS Co., Ltd. Asahi Kasei Medical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	常磐病院（福島県） 名港共立クリニック（愛知県） 偕行会城西病院（愛知県） 偕行会セントラルクリニック（愛知県） 鴨島川島クリニック（徳島県） 鳴門川島クリニック（徳島県） 中島土谷クリニック（広島県） 大町土谷クリニック（広島県） 新古賀クリニック（福岡県） 古賀病院21（福岡県） 伊都クリニック（福岡県） たかみや医院（熊本県）

Other administrative information
Date of disclosure of the study information	2014 Year 12 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 24 Day
Anticipated trial start date	2014 Year 09 Month 18 Day
Last follow-up date	2014 Year 11 Month 30 Day
Date of closure to data entry	2015 Year 10 Month 01 Day
Date trial data considered complete	2016 Year 06 Month 30 Day
Date analysis concluded	2017 Year 04 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 10 Day
Last modified on	2017 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017676