UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survey on fatigue of dialysis patients
Title of the study (Brief title)	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	Masaaki Nakayama
Organization	Tohoku University Hospital
Division name	Research Division of CKD and Dialysis treatment
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	Masaaki Nakayama
Organization	Tohoku University Hospital
Division name	Research Division of CKD and Dialysis treatment
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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