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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028555
Receipt No. 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

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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
Email 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
Email masaaki.nakayama.c1@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032681

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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