Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Kidney Transplantation

NCT ID: NCT02782416

Last Updated: 2016-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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

Conditions

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Kidney Transplantation

Keywords

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Renal Latent Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

Not waiting for renal transplant

Dialysis patients who are not waiting for renal transplant

Group Type PLACEBO_COMPARATOR

Examination of latent tuberculosis

Intervention Type OTHER

Status post renal transplant

patients who have received renal transplant

Group Type OTHER

Examination of latent tuberculosis

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Examination of latent tuberculosis

Intervention Type OTHER

Interventions

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Examination of latent tuberculosis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chin-Chung Shu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chin-Chung Shu, MD

Role: CONTACT

Phone: +886972653087

Email: [email protected]

Facility Contacts

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Chin-Chung Shu, MD

Role: primary

Other Identifiers

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201309056RINC

Identifier Type: -

Identifier Source: org_study_id