Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

A Randomized Study for Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Patients Preparing for Kidney Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02782416
• Other study ID #: 201309056RINC
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2016
• Last updated: December 13, 2016
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: National Taiwan University Hospital
• Contact: Chin-Chung Shu, MD
• Phone: +886972653087
• Email: ccshu139[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Kidney Transplantation
• Latent Tuberculosis
• Tuberculosis

Intervention

Other:
• Examination of latent tuberculosis

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of active TB		4 years	No