UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Trial for evaluation of the clinical effect of on line hemodiafiltration (HDF) and beta2-microglobulin adsorption column combination therapy.
Title of the study (Brief title)	Clinical Trial for evaluation of the clinical effect of on line hemodiafiltration (HDF) and beta2-microglobulin adsorption column combination therapy.
Region	Japan

Condition
Condition	dialysis-related amyloidosis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of on line HDF and beta2-microglobulin adsorption column therapy for long-term hemodialysis patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of clinical symptoms, circulatory dynamics, and nutritional and inflammatory status.
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	Device,equipment
Interventions/Control_1	Change from hemodialysis (HD) to on line HDF (1st phase: for 4 months) Combine on line HDF and beta2-microglobulin adsorption column. (2nd phase: for 4 months) Return from on line HDF and beta2-microglobulin adsorption column combination to on line HDF only (3rd phase, same as 1st phase: for 4 months)
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 has initiated hemodialysis before more than 10 years. (2)Patients with dialysis-related amyloidosis or similar symptoms.
Key exclusion criteria	Nothing
Target sample size	40

Research contact person
Name of lead principal investigator	Takeshi Nakanishi
Organization	Hyogo College of Medicine
Division name	Division of Kidney and Dialysis, Department of Internal Medicine
Address	1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6521
Email	kuragano@hyo-med.ac.jp

Public contact
Name of contact person	Takahiro Kuragano
Organization	Hyogo College of Medicine
Division name	Division of Kidney and Dialysis, Department of Internal Medicine
Address	1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL	0798-45-6521
Homepage URL
Email	kuragano@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Miyamoto Clinic Motomachi HD Clinic Hiwasa Clinic
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

Other administrative information
Date of disclosure of the study information	2012 Year 11 Month 29 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 10 Month 01 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2012 Year 11 Month 29 Day
Last modified on	2016 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010676