UMIN-ICDS Clinical Trial

Public title

A prospective cohort study on dietary nutrients intake for prognosis prediction in chronic hemodialysis patients-SUDACHI-STUDY-

Acronym

A prospective cohort study on dietary nutrients intake for prognosis prediction in chronic hemodialysis patients

Scientific Title

A prospective cohort study on dietary nutrients intake for prognosis prediction in chronic hemodialysis patients

Scientific Title:Acronym

SUDACHI-STUDY

Region

Japan

Condition

maintenance dialysis patients

Classification by specialty

Medicine in general

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

to perform the dietary surveillance and to evaluate the nutrition intake of the maintenance dialysis patients who is at low malnutrition risk as judged by NRI-JH classification

Basic objectives2

Others

Basic objectives -Others

To follw the prognosis of the object patients

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The information from medical records including personal data, anthropological data, and biochemical data, dietary hearing, nutrition aseccment, some additional biochemical data related to nutrition status, information about drug, treatment or dialysis modality
The prognosis of the object patients

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. The maintenance dialysis patients who are classified into the low risk group (below 7 by NRI-JH scoring system)
2. Those who are able to undertake the food record survellace by qualified clinical nutritians
3. Outpatients who undergo in-center hemodialysis (HD) or hemofiltodialysis (HDF) at least trice a week for at least two years
4. Those who agree to participate in this study voluntarily and can provide the written informed consent or those who have a related person who provide a writte document in their place in case the patients cannot afford to provide a written document

Key exclusion criteria

1. The patients under the treatment to severe infectious disease
2. The patients under the treatment to malignant neoplasm
3. Pregnant patients or those hope for pregnancy
4. The patients severely injured
5. The patients with amputated limbs
6. The patients treated with the hybrid therapy of peritoneal dialysis and HD or HDF
7. The patients who are considered to be ineligible to the inclusion to the study as judged by responsible doctors for the study

Target sample size

400

Name of lead principal investigator

1st name	Shu
Middle name
Last name	Wakino

Organization

Institute of Biomedical Sciences, Tokushima University Graduate School

Division name

Department of Nephrology

Zip code

770-8503

Address

3-18-15, Kuramoto-cho, Tokushima city, Tokushima prefecture

TEL

81-88-633-7183

Email

shuwakino@tokushima-u.ac.jp

Name of contact person

1st name	Michihiro
Middle name
Last name	Hosojima

Organization

Institute of Biomedical Sciences, Tokushima University Graduate School

Division name

Department of Clinical Nutrition Science, Kidney Research Center

Zip code

951-8510

Address

1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata 951-8510, Japan

TEL

+81-25-368-9312

Homepage URL

Email

hoso9582@med.niigata-u.ac.jp

Institute

Department of Clinical Nutrition Science, Kidney Research Center, Niigata University Graduate School of Medical and Dental Sciences

Institute

Department

Personal name

Organization

The Japanese Society for Dialysis Therapy

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Eiichiro Kanda
Medical Science, Kawasaki Medical School
577 Matsushima, Kurashiki, Okayama, 701-0192, Japan
TEL +81-86-462-1111

Name of secondary funder(s)

Organization

The Ethics Committee of Tokushima University Hospital

Address

3-18-15, Kuramoto-cho, Tokushima city, Tokushima prefecture

Tel

+81-88-633-7958

Email

brinshoshienk@tokushima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

徳島大学病院、川崎医科大学病院、新潟大学病院

Date of disclosure of the study information

2023

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

04

Month

23

Day

Date of IRB

Anticipated trial start date

2023

Year

06

Month

01

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

3-year observation study
The assessment of incidence of following events
1. Sarcopenia and frailty
2. Cardiovascular events
3. Severe infectious disease
4. Malignant neoplasm
5. Hospitalization
6. mortality

Registered date

2023

Year

03

Month

19

Day

Last modified on

2023

Year

07

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057594