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

Mahidol University160 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

160

Conditions

Tuberculosis (TB)End-Stage Kidney Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, Thailand

RECRUITING

Outcomes

Primary Outcomes

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. 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

Central Contacts

Tanaya Siripoon, M.D.

CONTACT

6626435599 Tanaya.sir@mahidol.edu

Punnee Pitisuttithum, Prof. E.

CONTACT

6626435599 punnee.pit@mahidol.ac.th

Data from ClinicalTrials.gov

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