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Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Kidney Transplantation

Primary Purpose

Kidney Transplantation

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Examination of latent tuberculosis
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Kidney Transplantation focused on measuring Renal, Latent, Tuberculosis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Placebo Comparator

Other

Experimental

Arm Label

Waiting for renal transplant_no screening of LTBI

Not waiting for renal transplant

Status post renal transplant

Waiting for renal transplant_ screening of LTBI

Arm Description

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

Dialysis patients who are not waiting for renal transplant

patients who have received renal transplant

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

Outcomes

Primary Outcome Measures

percentage of active TB

Secondary Outcome Measures

Full Information

First Posted
May 11, 2016
Last Updated
December 13, 2016
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02782416
Brief Title
Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Kidney Transplantation
Official Title
A Randomized Study for Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Patients Preparing for Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation
Keywords
Renal, Latent, Tuberculosis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Waiting for renal transplant_no screening of LTBI
Arm Type
No Intervention
Arm Description
patients with renal failure and are waiting for renal transplant We do routine examination but no LTBI check
Arm Title
Not waiting for renal transplant
Arm Type
Placebo Comparator
Arm Description
Dialysis patients who are not waiting for renal transplant
Arm Title
Status post renal transplant
Arm Type
Other
Arm Description
patients who have received renal transplant
Arm Title
Waiting for renal transplant_ screening of LTBI
Arm Type
Experimental
Arm Description
patients with renal failure and are waiting for renal transplant We do routine examination in addition to LTBI check
Intervention Type
Other
Intervention Name(s)
Examination of latent tuberculosis
Primary Outcome Measure Information:
Title
percentage of active TB
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 20-65 and match one of below Waiting renal transplant or status post renal transplant Receiving long term dialysis Exclusion Criteria: Not agree to be enrolled Suspected active TB HIV patients Viral hepatitis Using immunosuppressants within 3 months before enrollment Receiving lymphokine therapy Hemoglobin < 8 g/dL Serum bilirubin > 2.5 mg/dL AST or ALT > 2 times of upper normal limit Lactation or pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chin-Chung Shu, MD
Phone
+886972653087
Email
ccshu139@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin-Chung Shu, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chin-Chung Shu, MD
Phone
+886972653087
Email
ccshu139@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Kidney Transplantation

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