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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Tanaya Siripoon, M.D.; Phone Number: 6626435599; Email: Tanaya.sir@mahidol.edu
• Study Contact Backup: Name: Punnee Pitisuttithum, Prof. E.; Phone Number: 6626435599; Email: punnee.pit@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Recruiting
    • Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
160 End-stage renal disease patients; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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:	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	A prospective cohort study with following up period 2 years

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: National Research Council of Thailand
• Investigators: Study Chair: Punnee Pitisuttithum, Prof. E., Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Tuberculosis; Interferon gamma release assays; Subclinical Tuberculosis; End-stage Kidney Disease; Detection of Subclinical Tuberculosis; IGRAs
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Infections; Renal Insufficiency; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Renal Insufficiency, Chronic; Actinomycetales Infections; Mycobacterium Infections; Kidney Diseases; Kidney Failure, Chronic; Tuberculosis
• Other Study ID Numbers: NRCT9-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No