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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06700876

Enrollment

160

Registered

2024-11-22

Start date

2024-08-06

Completion date

2027-06-30

Last updated

2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Kidney Disease, Tuberculosis (TB)

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Thailand

Contacts

Primary ContactTanaya Siripoon, M.D.

Tanaya.sir@mahidol.edu6626435599

Backup ContactPunnee Pitisuttithum, Prof. E.

punnee.pit@mahidol.ac.th6626435599

Outcome results