UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059926 |
|---|---|
| Receipt number | R000068537 |
| Scientific Title | Restless Legs Syndrome in Patients with End-Stage Renal Disease |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/29 16:37:48 |
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Basic information
Public title
Clinical Study of Restless Legs Syndrome in Patients with End-Stage Renal Disease
Acronym
Restless Legs Syndrome in Patients with End-Stage Renal Disease
Scientific Title
Restless Legs Syndrome in Patients with End-Stage Renal Disease
Scientific Title:Acronym
Restless Legs Syndrome in Patients with End-Stage Renal Disease
Region
| Japan |
Condition
Condition
Restless Legs Syndrome
Classification by specialty
| Medicine in general | Nephrology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical characteristics of restless legs syndrome in patients with end-stage renal failure.
Basic objectives2
Others
Basic objectives -Others
Not applicable.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence and Severity of Restless Legs Syndrome by Dialysis Therapy (Hemodialysis and Peritoneal Dialysis)
Key secondary outcomes
The Relationship Between Restless Legs Syndrome and Dialysis Therapy (Depending on Dialysis Type and Conditions) and Laboratory Findings
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients currently receiving dialysis therapy (hemodialysis or peritoneal dialysis) at Fukuoka Red Cross Hospital, Maeda Hospital, and Hirakawa Clinic.
Key exclusion criteria
Patients who declined to participate in this study, and patients unable to complete the questionnaire
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | KENTARO |
| Middle name | |
| Last name | NAKAI |
Organization
Japanese Red Cross Fukuoka Hospital
Division name
Division of Nephrology and Dialysis Center
Zip code
815-8555
Address
3-1-1 Ogusu, Minami-ku, Fukuoka, 815-8555, Japan
TEL
+81-92-521-1211
kentaro-kyu@umin.org
Public contact
Name of contact person
| 1st name | KENTARO |
| Middle name | |
| Last name | NAKAI |
Organization
Japanese Red Cross Fukuoka Hospital
Division name
Division of Nephrology and Dialysis Center
Zip code
815-8555
Address
3-1-1 Ogusu, Minami-ku, Fukuoka, 815-8555, Japan
TEL
+81-92-521-1211
Homepage URL
kentaro-kyu@umin.org
Sponsor or person
Institute
Division of Nephrology and Dialysis Center,
Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan
Institute
Department
Personal name
Kentaro Nakai
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Maeda Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Red Cross Hospital Clinical Research Center
Address
3-1-1 Ogusu, Minami-ku, Fukuoka, 815-8555, Japan
Tel
0570-03-1211
fukuoka-kenkyu@fukuoka-med.jrc.or.jp
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
福岡赤十字病院（福岡県），医療法人幸善会前田病院（佐賀県），平川内科クリニック（福岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study investigates the prevalence and severity of restless legs syndrome (RLS) in patients with end-stage renal disease undergoing dialysis therapy (hemodialysis or peritoneal dialysis) using a questionnaire assessing RLS diagnosis and severity. Additionally, patient information, medical procedures, and test results obtained during routine clinical care will be collected to evaluate their association with RLS diagnosis and severity.
Management information
Registered date
| 2025 | Year | 11 | Month | 29 | Day |
Last modified on
| 2025 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068537
