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Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Kidney Transplantation

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ClinicalTrials.gov Identifier: NCT02782416
Recruitment Status : Recruiting
First Posted : May 25, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Kidney Transplantation Other: Examination of latent tuberculosis Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Randomized Study for Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Patients Preparing for Kidney Transplantation
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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
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



Primary Outcome Measures :
  1. percentage of active TB [ Time Frame: 4 years ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02782416


Contacts
Contact: Chin-Chung Shu, MD +886972653087 ccshu139@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chin-Chung Shu, MD    +886972653087    ccshu139@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chin-Chung Shu, MD National Taiwan University Hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02782416     History of Changes
Other Study ID Numbers: 201309056RINC
First Posted: May 25, 2016    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by National Taiwan University Hospital:
Renal
Latent
Tuberculosis

Additional relevant MeSH terms:
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections