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

What this Trial Is About

Researchers are conducting an observational study involving about 160 patients with end-stage renal disease (ESRD) who are on renal replacement therapy or have received a living donor or deceased donor kidney transplant. The study focuses on detecting latent and subclinical tuberculosis (TB) in these patients by evaluating interferon-gamma release assays (IGRA), symptom development, sputum Xpert MTB/RIF assay, and chest radiographs. This research aims to understand the proportion of positive IGRA results associated with TB symptoms and diagnostic tests in this high-risk group. Participants include adults aged 18 years or older who have ESRD and are either undergoing hemodialysis or peritoneal dialysis or have undergone kidney transplantation. There are no treatment interventions as this is an observational study. Researchers will monitor participants over a two-year follow-up period to identify latent TB infection and active TB cases using IGRA tests, symptom screening, sputum tests, and chest X-rays. During the study, participants will undergo scheduled assessments including IGRA testing, symptom evaluation, sputum Xpert MTB/RIF assay, and chest radiographs to detect TB infection. The main outcomes measured are the number of participants with positive IGRA tests and those diagnosed with latent or active TB during the two-year follow-up. No experimental treatments are given, and participants will continue their usual medical care throughout the study period.

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