Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Kidney Transplantation

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

Sponsors

Lead Sponsor: National Taiwan University Hospital

Source National Taiwan University Hospital
Brief Summary

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

Detailed Description

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

Overall Status Unknown status
Start Date January 2014
Completion Date December 2017
Primary Completion Date December 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
percentage of active TB 4 years
Enrollment 800
Condition
Intervention

Intervention Type: Other

Intervention Name: Examination of latent tuberculosis

Eligibility

Criteria:

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

Gender: All

Minimum Age: 20 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Chin-Chung Shu, MD Principal Investigator National Taiwan University Hospital
Overall Contact

Last Name: Chin-Chung Shu, MD

Phone: +886972653087

Email: [email protected]

Location
Facility: Status: Contact: National Taiwan University Hospital Chin-Chung Shu, MD +886972653087 [email protected]
Location Countries

Taiwan

Verification Date

December 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Waiting for renal transplant_no screening of LTBI

Type: No Intervention

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

Label: Not waiting for renal transplant

Type: Placebo Comparator

Description: Dialysis patients who are not waiting for renal transplant

Label: Status post renal transplant

Type: Other

Description: patients who have received renal transplant

Label: Waiting for renal transplant_ screening of LTBI

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Screening

Masking: None (Open Label)

Source: ClinicalTrials.gov