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

Recruiting

• Conditions: Tuberculosis (TB); End-Stage Kidney Disease

• Registration Number: NCT06700876
• Lead Sponsor: Mahidol University

Brief 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.

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.

Study Timeline

• Study Start: 2024-08-06
• Study First Submitted: 2024-10-07
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The number of participants with positive IGRAs among end-stage kidney disease and kidney transplant patients	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. 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:	A prospective cohort study with following up period 2 years	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

Trial Locations

Locations (1)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University; 🇹🇭 Bangkok, Thailand