UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation of changes in salty taste induced by the initiation of renal replacement therapy by salt-implegnated test strip
Acronym	The evaluation of changes in salty taste induced by renal replacement therapy
Scientific Title	The evaluation of changes in salty taste induced by the initiation of renal replacement therapy by salt-implegnated test strip
Scientific Title:Acronym	The evaluation of changes in salty taste induced by renal replacement therapy
Region	Japan

Condition
Condition	Chronic Kidney Disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will evaluate whether renal replacement therapy for end-stage renal dysfunction improves salty disorder in the hemodialysis group and living kidney transplantation group and further evaluate changes of salty taste in each group and the comparison of the two groups Moreover, we will identify the factors related to the changes in salty taste in each group
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. To examine whether there is a significant changes in salty taste using filter paper containing salt before and after renal replacement therapy; the initiation of hemodialysis or the living kidney transplantation 2. Differences in changes of salty taste between the hemodialysis group and the living kidney transplantation group 3 To identify the independent factors related to changes of salty taste
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. hemodialysis initiated patients 2. Living kidney transplant patients
Key exclusion criteria	1. Cases where evaluation using salt-containing filter paper is not possible due to impaired consciousness or respiratory failure 2. Patients who did not agree to participate in this clinical trial
Target sample size	100

Research contact person
Name of lead principal investigator	1st name JUN Middle name Last name INO
Organization	Toda Central General Hospital
Division name	Department of Nephrology
Zip code	335-0023
Address	1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
TEL	040-442-1111
Email	pikkun46@hotmail.com

Public contact
Name of contact person	1st name JUN Middle name Last name INO
Organization	Toda Central General Hospital
Division name	Department of Nephrology
Zip code	335-0023
Address	1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
TEL	048-442-1111
Homepage URL
Email	pikkun46@hotmail.com

Sponsor
Institute	Toda Central General Hospital
Institute
Department

Funding Source
Organization	Toda Central General Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Toda Central General Hospital
Address	1-19-3 Hon-cho, Toda city, Saitama, 335-0023, Japan
Tel	048-442-1111
Email	iryouhisho@chuobyoin.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

Other administrative information
Date of disclosure of the study information	2020 Year 04 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	Open public recruiting
Date of protocol fixation	2020 Year 03 Month 01 Day
Date of IRB	2020 Year 03 Month 23 Day
Anticipated trial start date	2020 Year 03 Month 31 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We will evaluate the change of salty taste before and after the initiation of renal replacement therapy. At the same time, we will observe the relationship between changes in taste and factors that may affect taste, such as uremic substances and zinc, and social backgrounds, such as smoking.

Management information
Registered date	2020 Year 03 Month 31 Day
Last modified on	2020 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045609

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.