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

NCT06700876 | Recruiting

• 1 other identifier: NRCT9-5
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis (TB); End-Stage Kidney Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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:

  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

  A prospective cohort study with following up period 2 years

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Positive PPD test or a previously documented positive PPD
• Active pulmonary or extrapulmonary tuberculosis

Sponsors & Collaborators

• Mahidol University: lead
• National Research Council of Thailand: collaborator

Study Sites (1)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, 10400, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for IGRAs, Sputum MTB/RIF Xpert (Only the subject whose blood for IGRAs results are positive )

MeSH Terms

Conditions

Tuberculosis; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Punnee Pitisuttithum, Prof. E.

  Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

  STUDY CHAIR

Central Study Contacts

Tanaya Siripoon, M.D.

CONTACT

6626435599; Tanaya.sir@mahidol.edu

Punnee Pitisuttithum, Prof. E.

CONTACT

6626435599; punnee.pit@mahidol.ac.th

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: November 22, 2024
• Study Start: August 6, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)