UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of suvorexant on sleep disorder and clinical findings of hemodialysis patients
Title of the study (Brief title)	The effects of suvorexant on sleep disorder and clinical findings of hemodialysis patients
Region	Japan

Condition
Condition	Insomnia, maintenance hemodialysis patient
Classification by specialty	Nephrology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1. To evaluate the effect and safety of suvorexant for maintenance blood dialysis patients with sleep disorder 2. To evaluate the effect of suvorexant for clinical findings related to hemodialysis treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Athens insomnia scale
Key secondary outcomes	1. Adverse effects 2. Self administered questionnaire about insomnia 3. Clinical findings (BMI, pre dialysis blood pressure, interdialytic weight gain, change of blood pressure during dialysis) and blood examinations

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The patients receive Suvorexant 20mg per day for 3 months. If the patients are elderly, they receive Suvorexant 15mg per day for 3 months. If the patients are already receiving other sleeping pills, we add Suvorexant to them.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients who receiving maintenance blood dialysis patients 2.Patients with insomnia 3.Patients who gave their written informed consent to participate for the present study 4.Age is 20 years old or more and gender is male or female
Key exclusion criteria	1. Severe liver dysfunction 2. Severe respiratory dysfunction 3. Severe brain disorder 4. Patients having agents inhibiting CYP3A 5. Patients with severe dementia 6. Patients with no sleep wake rhythm due to bedridden state
Target sample size	50

Research contact person
Name of lead principal investigator	Jun Ino
Organization	Toda Central General Hospital
Division name	Department of Nephrology
Address	1-19-3 Hon-tyou, Toda city, Saitama
TEL	048-442-1111
Email	pikkun46@hotmail.com

Public contact
Name of contact person	Jun Ino
Organization	Toda Central General Hospital
Division name	Department of Nephrology
Address	1-19-3 Hon-tyou, Toda city, Saitama
TEL	048-442-1111
Homepage URL
Email	pikkun46@hotmail.com

Sponsor
Institute	Toda Central General Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	2016 Year 07 Month 16 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 18 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	2016 Year 07 Month 16 Day
Last modified on	2016 Year 07 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026720