To Predict the Potential of Development of Active Tuberculosis in Those Receiving Long-term Dialysis by Using Interferon-gamma Release AssyNCT01311999
Surveillance and Follow-up for Latent Tuberculosis Infection and Risk of Developing Active Tuberculosis in Patients Receiving Long-term Dialysis
An observational study of To Predict the Potential of Development of Active Tuberculosis in Those Receiving Long-term Dialysis by Using Interferon-gamma Release Assy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To follow-up the latent tuberculosis infection and the risk of developing active tuberculosis in patients receiving long-term dialysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Predict the Potential of Development of Active Tuberculosis in Those Receiving Long-term Dialysis by Using Interferon-gamma Release Assy
- How many people
- 234 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2011to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients receiving long-term dialysis
Who may be able to join
- age equal to or more than 18-years old
- having received dialysis more than 3 months
Who cannot join
- Positive HIV test
- Liver cirrhosis, Child-Pugh class C
- Receiving long-term systemic corticosteroid use
- Receiving chemotherapy within recent three months
- Life span is less than one year
- Being suspected to have active tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
To follow-up the latent tuberculosis infection and the risk of developing active tuberculosis in patients receiving long-term dialysis
Read the detailed description
Tuberculosis (TB) remains an important infectious disease worldwide. Taiwan is still an edemic area. In 2008, there is an incidence of 62 persons having TB per 100,000 population. To control TB, we should prevent further TB transmission via early diagnosis and treatment of latent TB. In screening the risk population for TB, patients with renal failure acquiring long-term dialysis, in addition to close contacts, have higher incidence and mortality than general population. Moreover, the risk for active TB in dialysis patients is ten to 25 times larger. In Taiwan, the dialysis group is important because it has higher prevalence (2228 per in per million people by 2009 annual report of United States Renal Data System) than other countries in the world. In particular, the dialysis patients usually has an extrapulmonary presentation for their TB, so diagnosis is always delay. Hence, we should detect latent TB in those dialysis patients for monitor them from active tuberculosis.
Currently, interferon-gamma release assays (IGRAs) are used for finding out those with latent TB and have been proven useful for those being immunocompromised, and having BCG vaccination. For dialysis patients, IGRAs have been tested and been considered better than skin tuberculin test. However, previous studied rarely observed the patients receiving peritoneal dialysis. Besides, those cross-sectional studies used the indirect evidence for diagnosis and lacked longitudinal follow-up. We thus conducted this study for observing the prevalence of latent TB in those receiving hemodialysis or peritoneal dialysis by using IGRAs. We also kept one-year follow-up for the primary outcome of active TB occurrence.
- Keywords
- latent tuberculosis, renal failure, dialysis, interferon-gamma release assay
- Medical subject headings
- Latent Tuberculosis, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IGRA-positive group | The subjects who have positive results of interferon-gamma release assay | |
| IGRA-negative group | The subjects who have negative results of interferon-gamma release assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of active tuberculosis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Predict the Potential of Development of Active Tuberculosis in Those Receiving Long-term Dialysis by Using Interferon-gamma Release AssyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chin-Chung Shu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311999
- Sponsor's protocol ID
- 201009057R
- Status last verified
- Dec 2013
- First submitted
- 8 Mar 2011
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance and Follow-up for Latent Tuberculosis Infection and Risk of Developing Active Tuberculosis in Patients Receiving Long-term Dialysis
- ClinicalTrials.gov ID
- NCT01311999
- Acronym / sponsor ID
- 201009057R
- Keywords
- latent tuberculosis, renal failure, dialysis, interferon-gamma release assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To follow-up the latent tuberculosis infection and the risk of developing active tuberculosis in patients receiving long-term dialysis
Detailed description
Tuberculosis (TB) remains an important infectious disease worldwide. Taiwan is still an edemic area. In 2008, there is an incidence of 62 persons having TB per 100,000 population. To control TB, we should prevent further TB transmission via early diagnosis and treatment of latent TB. In screening the risk population for TB, patients with renal failure acquiring long-term dialysis, in addition to close contacts, have higher incidence and mortality than general population. Moreover, the risk for active TB in dialysis patients is ten to 25 times larger. In Taiwan, the dialysis group is important because it has higher prevalence (2228 per in per million people by 2009 annual report of United States Renal Data System) than other countries in the world. In particular, the dialysis patients usually has an extrapulmonary presentation for their TB, so diagnosis is always delay. Hence, we should detect latent TB in those dialysis patients for monitor them from active tuberculosis.
Currently, interferon-gamma release assays (IGRAs) are used for finding out those with latent TB and have been proven useful for those being immunocompromised, and having BCG vaccination. For dialysis patients, IGRAs have been tested and been considered better than skin tuberculin test. However, previous studied rarely observed the patients receiving peritoneal dialysis. Besides, those cross-sectional studies used the indirect evidence for diagnosis and lacked longitudinal follow-up. We thus conducted this study for observing the prevalence of latent TB in those receiving hemodialysis or peritoneal dialysis by using IGRAs. We also kept one-year follow-up for the primary outcome of active TB occurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGRA-positive group | – | –The subjects who have positive results of interferon-gamma release assay |
| IGRA-negative group | – | –The subjects who have negative results of interferon-gamma release assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients receiving long-term dialysis
Key inclusion criteria (2 listed)
- age equal to or more than 18-years old
- having received dialysis more than 3 months
Key exclusion criteria (6 listed)
- Positive HIV test
- Liver cirrhosis, Child-Pugh class C
- Receiving long-term systemic corticosteroid use
- Receiving chemotherapy within recent three months
- Life span is less than one year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of active tuberculosis
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chin-Chung Shu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Predict the Potential of Development of Active Tuberculosis in Those Receiving Long-term Dialysis by Using Interferon-gamma Release Assy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of active tuberculosis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2013; AzTrials last refreshed its copy on 8 Nov 2026.