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NCT Number: NCT06700876

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

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.

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Key information

Conditions

Tuberculosis (TB) Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Chronic Disease Disease Attributes End-stage Kidney Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gram-Positive Bacterial Infections Infections Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mycobacterium Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Tuberculosis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, 10400, Thailand

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Positive PPD test or a previously documented positive PPD
  • Active pulmonary or extrapulmonary tuberculosis

Treatment and study plan

Primary outcomes

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

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

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

  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:

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

    • Latent TB: a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens (positive IGRA) with no evidence of clinically manifest active TB
    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Punnee Pitisuttithum, Prof. E.

CONTACT

[email protected]

6626435599

Tanaya Siripoon, M.D.

CONTACT

[email protected]

6626435599

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • National Research Council of Thailand

Registry information

Official study title

Evaluation of Interferon-gamma Release Assays, Symptom Screening and Chest Radiograph for Detection of Subclinical Tuberculosis of End-stage Kidney Disease and Kidney Transplant Recipients in Thailand

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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