UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of melatonin receptor agonist on hemodialysis patients with sleep disturbance
Title of the study (Brief title)	The effect of melatonin receptor agonist on hemodialysis patients
Region	Japan

Condition
Condition	hemodialysis patients with sleep disturbance
Classification by specialty	Nephrology Neurology Psychosomatic Internal Medicine Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of ramelteon receptor agonist for hemodialysis patients with sleep disturbance
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Interview form and objective assessmennt during hemodialysis
Key secondary outcomes	Variability of blood pressure

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	hemodialysis patient with sleep disturbance
Key exclusion criteria	Patient who have the contraindication for ramelteon.
Target sample size	40

Research contact person
Name of lead principal investigator	Kazuaki Soejima
Organization	Saiseikai Kumamoto Hospital
Division name	kidney and urology center
Address	Chikami 5-3-1,Minami-ku, Kumamoto
TEL	096-351-8000
Email	hironobu-inoue@saiseikaikumamoto.jp

Public contact
Name of contact person	Hironobu Inoue
Organization	Saiseikai Kumamoto Hospital
Division name	kidney and urology center
Address	Chikami 5-3-1,Minami-ku, Kumamoto
TEL	096-351-8000
Homepage URL
Email	hironobu-inoue@saiseikaikumamoto.jp

Sponsor
Institute	Saiseikai Kumamoto Hospital
Institute
Department

Funding Source
Organization	Saiseikai Kumamoto Hospital
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 06 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 08 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date	2014 Year 06 Month 30 Day
Date of closure to data entry	2014 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2013 Year 06 Month 08 Day
Last modified on	2017 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012766