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 |
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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
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
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
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
