Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Kidney Transplantation

National Taiwan University

Status: Unknown

Conditions: Kidney Transplantation

Treatments: Other: Examination of latent tuberculosis

Study type: Interventional

Funder types: Other

Identifiers

NCT02782416

201309056RINC

Details and patient eligibility

About

Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the incidence of active TB

Full description

Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the incidence of active TB

Enrollment: 800 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 20-65 and match one of below
2. Waiting renal transplant or status post renal transplant
3. Receiving long term dialysis

Exclusion criteria

1. Not agree to be enrolled
2. Suspected active TB
3. HIV patients
4. Viral hepatitis
5. Using immunosuppressants within 3 months before enrollment
6. Receiving lymphokine therapy
7. Hemoglobin < 8 g/dL
8. Serum bilirubin > 2.5 mg/dL
9. AST or ALT > 2 times of upper normal limit
10. Lactation or pregnancy

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 4 patient groups, including a placebo group

Waiting for renal transplant_no screening of LTBI

No Intervention group

Description:

patients with renal failure and are waiting for renal transplant We do routine examination but no LTBI check

Not waiting for renal transplant

Placebo Comparator group

Description:

Dialysis patients who are not waiting for renal transplant

Treatment:

Other: Examination of latent tuberculosis

Status post renal transplant

Other group

Description:

patients who have received renal transplant

Treatment:

Other: Examination of latent tuberculosis

Waiting for renal transplant_ screening of LTBI

Experimental group

Description:

patients with renal failure and are waiting for renal transplant We do routine examination in addition to LTBI check

Treatment:

Other: Examination of latent tuberculosis