UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058182
Receipt number R000066413
Scientific Title A multicenter study on the significance of IGRA screening for the diagnosis of latent tuberculosis infection in patients initiating hemodialysis
Date of disclosure of the study information 2025/06/20
Last modified on 2025/06/16 11:03:18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A multicenter study on the significance of IGRA screening for the diagnosis of latent tuberculosis infection in patients initiating hemodialysis

Acronym

Latent tuberculosis infection in patients initiating hemodialysis

Scientific Title

A multicenter study on the significance of IGRA screening for the diagnosis of latent tuberculosis infection in patients initiating hemodialysis

Scientific Title:Acronym

Latent tuberculosis infection in patients initiating hemodialysis

Region

Japan


Condition

Condition

Latent tuberculosis infection

Classification by specialty

Nephrology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the prevalence and characteristics of latent tuberculosis infection (LTBI) in patients initiating dialysis

Basic objectives2

Others

Basic objectives -Others

epidemiological study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Prevalence of latent tuberculosis infection (LTBI) in patients initiating hemodialysis

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

50 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

[Hemodialysis Group]
Male and Female aged 50 to under 90 years who are newly initiated on hemodialysis and do not meet any exclusion criteria.

[Control Group]
Male and Female aged 50 to under 90 years who do not meet any exclusion criteria.

Key exclusion criteria

Exclusion Criteria:
These criteria specify reasonable grounds for excluding individuals from the study population who otherwise meet the inclusion criteria.

1) Individuals with a history of tuberculosis

2) Individuals who have previously received treatment for latent tuberculosis infection (LTBI)

3) Individuals with a household member diagnosed with active tuberculosis

4) Individuals in the control group with an estimated glomerular filtration rate (eGFR) <= 45 mL/min/1.73m2

5) Individuals in the control group who are receiving specialized outpatient care for kidney disease

6) Individuals in the hemodialysis group undergoing temporary dialysis initiation, such as continuous hemodiafiltration (CHDF)

Target sample size

800


Research contact person

Name of lead principal investigator

1st name Ayumi
Middle name
Last name Yoshifuji

Organization

Keio University

Division name

School of Medicine, Department of Infectious Diseases

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-3-3353-1211

Email

jsdt.vaccine.antibody@gmail.com


Public contact

Name of contact person

1st name Tomoki
Middle name
Last name Nagasaka

Organization

Keio University

Division name

School of Medicine, Department of Infectious Diseases

Zip code

1608582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-3-3353-1211

Homepage URL


Email

jsdt.vaccine.antibody@gmail.com


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

Revvity Japan

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine Ethics Committee

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

+81-3-3353-1211

Email

med-rinri-jimu@adst.keio.ac.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

2025 Year 06 Month 20 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

2023 Year 08 Month 28 Day

Date of IRB

2023 Year 10 Month 11 Day

Anticipated trial start date

2023 Year 10 Month 12 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Participants will provide blood samples for the evaluation of IGRA. Basic survey forms will be completed by the collaborating and cooperating research institutions to collect information on patient background, presence or absence of tuberculosis onset, and other relevant data.


Management information

Registered date

2025 Year 06 Month 16 Day

Last modified on

2025 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066413