UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010909 |
|---|---|
| Receipt number | R000012766 |
| Scientific Title | The effect of melatonin receptor agonist on hemodialysis patients with sleep disturbance |
| Date of disclosure of the study information | 2013/06/08 |
| Last modified on | 2017/06/12 09:09:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of melatonin receptor agonist on hemodialysis patients with sleep disturbance
Acronym
The effect of melatonin receptor agonist on hemodialysis patients
Scientific Title
The effect of melatonin receptor agonist on hemodialysis patients with sleep disturbance
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kazuaki Soejima |
Organization
Saiseikai Kumamoto Hospital
Division name
kidney and urology center
Zip code
Address
Chikami 5-3-1,Minami-ku, Kumamoto
TEL
096-351-8000
hironobu-inoue@saiseikaikumamoto.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu Inoue |
Organization
Saiseikai Kumamoto Hospital
Division name
kidney and urology center
Zip code
Address
Chikami 5-3-1,Minami-ku, Kumamoto
TEL
096-351-8000
Homepage URL
hironobu-inoue@saiseikaikumamoto.jp
Sponsor or person
Institute
Saiseikai Kumamoto Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 08 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012766
