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
Sponsor study identifier
observational
160
1 country
1
Study Start
August 6, 2024
Actual (reported)Primary Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 6, 2024
Actual (reported)October 7, 2024
Actual (reported)November 22, 2024
Actual (reported)December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400, Thailand
Blood for IGRAs, Sputum MTB/RIF Xpert (Only the subject whose blood for IGRAs results are positive )
Punnee Pitisuttithum, Prof. E.
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
First Submitted
October 7, 2024
First Posted
November 22, 2024
Study Start
August 6, 2024
Actual (reported)Primary Completion
December 31, 2026
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 8, 2026
Record last verified: 2026-10
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