UMIN-ICDS Clinical Trial

Public title

Fukushima Dialysis Cohort Study: Association Between Patient-Reported Outcomes (PROs) and Prognosis in Patients Receiving Maintenance Hemodialysis

Acronym

Fukushima Dialysis Cohort Study

Scientific Title

Association Between Patient-Reported Outcomes (PROs) and Prognosis in Patients Receiving Maintenance Hemodialysis: Fukushima Dialysis Cohort Study

Scientific Title:Acronym

Fukushima Dialysis Cohort Study

Region

Japan

Condition

Patients receiving maintenance hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to longitudinally evaluate patient-reported outcomes (PROs), particularly health-related quality of life (HR-QOL), in patients receiving maintenance dialysis at multiple centers in Fukushima Prefecture, and to clarify their associations with prognosis. In addition, this study aims to identify factors associated with HR-QOL in order to provide evidence that may contribute to the development of indicators for QOL assessment, extension of healthy life expectancy, and optimization of dialysis-related healthcare resources in patients receiving maintenance dialysis.

Basic objectives2

Others

Basic objectives -Others

To evaluate longitudinal changes in patient-reported outcomes (PROs), particularly health-related quality of life, in patients receiving maintenance dialysis, and to clarify their associations with prognosis as well as factors associated with health-related quality of life.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

1. Longitudinal changes in health-related quality of life scores (EQ-5D-5L and EQ-VAS)
2. New-onset cardiovascular events, fractures, and death

Key secondary outcomes

Associations of baseline patient-reported outcomes, physical function, psychological measures, nutritional and dialysis-related parameters, medical history, lifestyle factors, treatment characteristics, and laboratory findings with HR-QOL and prognosis will be evaluated.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients receiving hemodialysis three or more times per week for at least 3 months at participating institutions during the enrollment period from February 2021 to February 2027
2.Age 18 years or older at enrollment
3.Written informed consent obtained from the patient or legally acceptable representative

Key exclusion criteria

1.Patients with active malignancy
2.Patients with active infection
3.Pregnant patients
4.Patients with psychiatric disorders or psychiatric symptoms judged to make participation in the study difficult

Target sample size

500

Name of lead principal investigator

1st name	Junichiro
Middle name	James
Last name	Kazama

Organization

Fukushima Medical University

Division name

Department of Nephrology and Hypertension

Zip code

960-1295

Address

1 Hikariga-oka, Fukushima City, Fukushima, Japan

TEL

+81-24-547-1111

Email

jjkaz@fmu.ac.jp

Name of contact person

1st name	Hirotaka
Middle name
Last name	Saito

Organization

Fukushima Medical University

Division name

Department of Nephrology and Hypertension

Zip code

960-1295

Address

1 Hikariga-oka, Fukushima City, Fukushima, Japan

TEL

+81-24-547-1111

Homepage URL

Email

qwertynation216@gmail.com

Institute

Fukushima Medical University

Institute

Department

Personal name

Junichiro James Kazama

Organization

self-funded

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Fukushima Medical University

Address

1 Hikariga-oka, Fukushima City, Fukushima, Japan

Tel

+81-24-547-1111

Email

fmurec@fmu.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

Date of disclosure of the study information

2026

Year

04

Month

17

Day

URL releasing protocol

Publication of results

Partially published

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

Open public recruiting

Date of protocol fixation

2020

Year

12

Month

15

Day

Date of IRB

2021

Year

01

Month

19

Day

Anticipated trial start date

2021

Year

02

Month

01

Day

Last follow-up date

2029

Year

01

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study design: prospective, multicenter, non-interventional observational cohort study
Participants: maintenance hemodialysis patients
Enrollment: eligible patients receiving care at participating institutions who provide written informed consent will be enrolled.
Assessments: clinical data including patient-reported outcomes (PROs) will be collected, and the associations of PROs with prognosis, as well as associations with patient characteristics and clinical parameters, will be examined.

Registered date

2026

Year

04

Month

17

Day

Last modified on

2026

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070134