NCT02782416

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 15, 2016

Status Verified

December 1, 2016

Enrollment Period

3.9 years

First QC Date

May 11, 2016

Last Update Submit

December 13, 2016

Conditions

Kidney Transplantation

Keywords

RenalLatentTuberculosis

Outcome Measures

Primary Outcomes (1)

  • percentage of active TB

    4 years

Study Arms (4)

Waiting for renal transplant_no screening of LTBI

NO INTERVENTION

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

Not waiting for renal transplant

PLACEBO COMPARATOR

Dialysis patients who are not waiting for renal transplant

Other: Examination of latent tuberculosis

Status post renal transplant

OTHER

patients who have received renal transplant

Other: Examination of latent tuberculosis

Waiting for renal transplant_ screening of LTBI

EXPERIMENTAL

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

Other: Examination of latent tuberculosis

Interventions

Examination of latent tuberculosisOTHER
Not waiting for renal transplantStatus post renal transplantWaiting for renal transplant_ screening of LTBI

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 20-65 and match one of below
  • Waiting renal transplant or status post renal transplant
  • Receiving long term dialysis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Chin-Chung Shu, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chin-Chung Shu, MD

CONTACT

+886972653087ccshu139@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 25, 2016

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 15, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)