UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory clinical trial of dialysis dose monitor with optical measurement
Title of the study (Brief title)	Exploratory clinical trial of dialysis dose monitor with optical measurement
Region	Japan

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

Objectives
Narrative objectives1	We investigate the accuracy of the dialysis dose monitor newly developed by Nikkiso Co., Ltd. by measuring correlations blood and the dialysate concentration of solute.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation with urea concentration of dialysis effluent and blood by the dialysis dose monitor
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	Dialysis therapy for a week using dialysis machine equipped with the dialysis dose monitor newly developed by Nikkiso Co., Ltd.
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	Stable regular dialysis patients without malnutrition, severe anemia, unstable blood pressure who gives written consent by his/her free will to the participation to the study after receiving sufficient explanation.
Key exclusion criteria	Severe hypertension over systolic pressure of 120 mmHg Significant recirculation of blood access Pregnat patients, suspected of being pregnant or lactating patients.
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Akiba
Organization	Tokyo Women's Medical University
Division name	Department of Blood Purification
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8112-20251
Email	takiba@kc.twmu.ac.jp

Public contact
Name of contact person	Isimori Isamu
Organization	Tokyo Women's Medical University
Division name	Department of Blood Purification
Address	8-1, Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	ishimori@kc.twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University Department of Blood Purification
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)

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	2013 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 18 Day
Anticipated trial start date	2013 Year 08 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	2013 Year 07 Month 01 Day
Last modified on	2017 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012651