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

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

Study Overview

• Status: Unknown
• Conditions: Kidney Transplantation
• Intervention / Treatment: Other: Examination of latent tuberculosis

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chin-Chung Shu, MD; Phone Number: +886972653087; Email: ccshu139@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waiting for renal transplant_no screening of LTBI; patients with renal failure and are waiting for renal transplant We do routine examination but no LTBI check
Placebo Comparator: Not waiting for renal transplant; Dialysis patients who are not waiting for renal transplant	Other: Examination of latent tuberculosis
Other: Status post renal transplant; patients who have received renal transplant	Other: Examination of latent tuberculosis
Experimental: Waiting for renal transplant_ screening of LTBI; patients with renal failure and are waiting for renal transplant We do routine examination in addition to LTBI check	Other: Examination of latent tuberculosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of active TB	4 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chin-Chung Shu, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: May 11, 2016
• First Submitted That Met QC Criteria: May 22, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 13, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Tuberculosis; Renal; Latent
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: 201309056RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO