Evaluation of IGRA, Symptoms and Chest Radiograph for Subclinical TB Detection in ESRD and KT
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMahidol University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Positive PPD test or a previously documented positive PPD
Active pulmonary or extrapulmonary tuberculosis
Trial 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
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
160 Participants
are grouped into 1 trial groupGroup A: 160 End-stage renal disease patients
Trial outcomes
Primary outcomes
1
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
Time frame
A prospective cohort study with following up period 2 years2
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
Time frame
A prospective cohort study with following up period 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mahidol University
Lead sponsor
National Research Council of Thailand
Collaborator
Source ClinicalTrials.gov