UMIN-CTR Clinical Trial

Basic information
Public title	Appetite assessment and analysis of factors affecting appetite loss in elderly hemodialysis patients
Acronym	Appetite assessment and analysis of factors affecting appetite loss in elderly hemodialysis patients
Scientific Title	Appetite assessment and analysis of factors affecting appetite loss in elderly hemodialysis patients
Scientific Title:Acronym	Appetite assessment and analysis of factors affecting appetite loss in elderly hemodialysis patients
Region	Japan

Condition
Condition	Hemodialysis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the appetite of elderly hemodialysis patients and analyze the factors that affect appetite loss.
Basic objectives2	Others
Basic objectives -Others	Factor analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SNAQ-JE score
Key secondary outcomes	Nutritional index(Albumin,GNRI,NRI-JH) Blood test(ChE,TO,T-Cho,UN,Cr,CRP,Hb,nPCR and others) Age, dialysis history, medical history, BMI and others

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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	outpatients dialysis patients
Key exclusion criteria	Patients who disagree with the questionnaire survey using SNAQ-JE
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Satoko Middle name Last name Notomi
Organization	Nagasaki Renal Center
Division name	Department of nutrition
Zip code	850-0032
Address	5-1,Kozenmachi,Nagasaki
TEL	095-824-1101
Email	s-notomi@nagajin.jp

Public contact
Name of contact person	1st name Satoko Middle name Last name Notomi
Organization	Nagasaki Renal Center
Division name	Department of nutrition
Zip code	850-0032
Address	5-1, Kozenmachi Nagasaki
TEL	095-824-1101
Homepage URL
Email	s-notomi@nagajin.jp

Sponsor
Institute	Nagasaki Renal Center
Institute
Department

Funding Source
Organization	None
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	Ethical committee of Nagasaki kidney hospital
Address	5-1,Kozenmachi. Nagasaki
Tel	095-824-1101
Email	r-koma@nagajin.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	21012
Org. issuing International ID_1	Ethical committee of Nagasaki kidney hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	長崎腎病院（長崎県）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 25 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	Terminated
Date of protocol fixation	2021 Year 09 Month 10 Day
Date of IRB	2021 Year 09 Month 10 Day
Anticipated trial start date	2021 Year 09 Month 10 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Cross-sectional study All patients who underwent hemodialysis at our facility in September-December 2021 who met the selection criteria

Management information
Registered date	2021 Year 09 Month 25 Day
Last modified on	2022 Year 09 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051882