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RecruitingNCT06700876Updated Nov 22, 2024

Evaluation of IGRA, Symptoms and Chest Radiograph for Subclinical TB Detection in ESRD and KT

An observational study in Tuberculosis (TB) and End-Stage Kidney Disease, sponsored by Mahidol University. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Mahidol University · Observational

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
160
Ages
18 Years and older
Sex
All
01

Study summary

This is an observational study among approximately 160 end-stage renal disease patients on renal replacement therapy and post-living donor or deceased donor kidney transplant recipients. Investigators aim to assess the proportion of positive IGRA associated with symptom development, sputum Xpert MTB/RIF assay, and chest radiograph to define latent TB infection and subclinical TB among ESKD and renal transplant patients.

Read the detailed description

Patients with chronic kidney disease and end-stage kidney disease (ESKD) are at risk of developing tuberculosis and are often delayed in diagnosis. Herein, investigators aim to assess the proportion of positive IGRA associated with symptom development, sputum Xpert MTB/RIF assay, and chest radiograph to define latent TB infection and subclinical TB among ESKD and renal transplant patients.

02

Conditions studied

  • Tuberculosis (TB)
  • End-Stage Kidney Disease

Keywords

  • Subclinical Tuberculosis
  • Interferon gamma release assays
  • End-stage Kidney Disease
  • Detection of Subclinical Tuberculosis
  • Tuberculosis
  • IGRAs
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's planned enrollment of 160 is below the median of 250 across 421 observational studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

End-stage renal disease on renal replacement therapy (hemodialysis or peritoneal dialysis) or status-post-living donor or deceased donor kidney transplantation aged more than or equal 18 years

Inclusion criteria

  1. End-stage renal disease on renal replacement therapy (hemodialysis or peritoneal dialysis) or status-post-living donor or deceased donor kidney transplantation
  2. Aged more than or equal 18 years

Exclusion criteria

Exclusion Criteria:

  1. Positive PPD test or a previously documented positive PPD
  2. Active pulmonary or extrapulmonary tuberculosis
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
160 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 160 End-stage renal disease patients

    End-stage renal disease on renal replacement therapy (hemodialysis or peritoneal dialysis) or status-post-living donor or deceased donor kidney transplantation aged more than or equal 18 years

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What researchers measure

Primary outcomes

  1. 1.The number of participants with positive IGRAs among end-stage kidney disease and kidney transplant patients

    The number of participants with positive IGRAs among end-stage kidney disease patients and kidney transplant patients

    Time frame: A prospective cohort study with following up period 2 years

  2. 2. The number of participants with latent TB and active TB among end-stage kidney disease and kidney transplant patients during the 2-year follow-up defined by:

    1. Latent TB: a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens (positive IGRA) with no evidence of clinically manifest active TB 2. Active TB: a disease in someone infected with Mycobacterium tuberculosis. It is characterized by signs or symptoms of active disease, or both, and is distinct from latent TB infection, which occurs without signs or symptoms of active disease

    Time frame: A prospective cohort study with following up period 2 years

07

Study locations

1 of 1 sites recruiting
  • Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
    Bangkok, 10400, Thailand
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06700876
Lead sponsor
Mahidol University
Collaborators
National Research Council of Thailand
Responsible party
Punnee Pitisuttithum (Professor, Mahidol University) — Principal investigator
First posted
Nov 22, 2024
Start date
Aug 6, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Nov 22, 2024

Study contacts

Tanaya Siripoon, M.D.
Contact
Tanaya.sir@mahidol.edu
6626435599
Punnee Pitisuttithum, Prof. E.
Contact
punnee.pit@mahidol.ac.th
6626435599
Punnee Pitisuttithum, Prof. E.
study chair · Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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