UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028555 |
|---|---|
| Receipt number | R000032681 |
| Scientific Title | Survey on fatigue of dialysis patients |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2017/08/06 12:16:54 |
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Basic information
Public title
Survey on fatigue of dialysis patients
Acronym
Dialysis fatigue
Scientific Title
Survey on fatigue of dialysis patients
Scientific Title:Acronym
Dialysis fatigue
Region
| Japan |
Condition
Condition
chronic dialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the status of fatigue in patients on chronic dialysis therapy, and to clarify the different profiles by dialysis modality
Basic objectives2
Others
Basic objectives -Others
clinical superiority of combination therapy
for fatigue suppression
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profile of fatigue grade by function of dialysis modalities
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic dialysis patients who are admitting to out-patient clinic
Key exclusion criteria
those who have acute illness
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Nakayama |
Organization
Tohoku University Hospital
Division name
Research Division of CKD and Dialysis treatment
Zip code
Address
1-1 Seiryo-match, Aoba-ku, Sendai, Miyagi
TEL
022-717-7393
masaaki.nakayama.c1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Nakayama |
Organization
Tohoku University Hospital
Division name
Research Division of CKD and Dialysis treatment
Zip code
Address
1-1 Seiryo-match, Aoba-ku, Sendai, Miyagi
TEL
022-717-7393
Homepage URL
masaaki.nakayama.c1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 11 | 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
| 2017 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multiple questionares
Management information
Registered date
| 2017 | Year | 08 | Month | 06 | Day |
Last modified on
| 2017 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032681
