Chronic Renal FailureNCT00695734
Detection of Latent Tuberculosis in Hemodialysis Patients
An observational study of Chronic Renal Failure, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
This study aims to compare the performance of the tuberculin skin test, used for more than 50 years as a diagnostic tool for latent tuberculosis infection, with 2 blood tests which have recently become commercially available (Interferon-gamma release assays) in a population of immunosuppressed individuals with chronic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure
- How many people
- 62 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2007to Jan 2008
- 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: Adults aged over 18 Under hemodialysis for > 3 months End stage renal failure
Who may be able to join
- Adults aged over 18
- Under hemodialysis for > 3 months
- End stage renal failure
Who cannot join
- Refusal to participate
- Prior tuberculin skin test > 15 mm or any adverse reaction to tuberculin skin test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interferon-Gamma Release Assays (IGRA) Versus Tuberculin Skin Testing for Detection of Latent Tuberculosis Infection (TB) in Chronic Hemodialysis Patients
This study aims to compare the performance of the tuberculin skin test, used for more than 50 years as a diagnostic tool for latent tuberculosis infection, with 2 blood tests which have recently become commercially available (Interferon-gamma release assays) in a population of immunosuppressed individuals with chronic renal failure undergoing long term hemodialysis
Read the detailed description
This prospective study includes all adults aged over 18 years of age who accept to be included in the study and provided written informed consent. All patients are under long term hemodialysis for chronic renal failure. They are subjected to a questionnaire including history of contacts with tuberculosis (TB), prior treatment for TB, history of prior tuberculin skin testing, history of BCG vaccination, country of origin, trips or prolonged stays in high incidence areas, smoking history, and medications. All patients will have a chest X-ray, and simultaneous testing with the tuberculin skin test according to the Mantoux technique, and with the T-SPOT. TB and QuantiFERON Gold in tube Interferon-gamma release assays. The study analysis agreement between tests, detection of prior TB and presumptive latent tuberculosis infection, based on these items.
- Conditions
- Chronic Renal Failure
- Keywords
- hemodialysis, end stage renal failure, tuberculosis, latent tuberculosis infection, Patients under hemodialysis for end stage renal failure
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Tuberculosis, Latent Tuberculosis
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 |
|---|---|---|
| Hemodialysis | Patients under chronic hemodialysis for chronic end stage renal failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative performance of tuberculin skin test and interferon gamma release assays for detecting latent tuberculosis infection
Measured: cross-sectionnal
Secondary outcomes (1)
Agreement between tuberculin skin test and interferon gamma release assays as well as agreement between interferon gamma release assays
Measured: cross-sectionnal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue Pulmonaire Genevoise
- Investigators
- Jean-Paul Janssens, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695734
- Sponsor's protocol ID
- JJanssens 4
- Status last verified
- Jun 2008
- First submitted
- 10 Jun 2008
- Last updated
- 12 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon-Gamma Release Assays (IGRA) Versus Tuberculin Skin Testing for Detection of Latent Tuberculosis Infection (TB) in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00695734
- Acronym / sponsor ID
- JJanssens 4
- Conditions
- Chronic Renal Failure
- Keywords
- hemodialysis, end stage renal failure, tuberculosis, latent tuberculosis infection, Patients under hemodialysis for end stage renal failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Ligue Pulmonaire Genevoise
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 Jun 2008 (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.
This study aims to compare the performance of the tuberculin skin test, used for more than 50 years as a diagnostic tool for latent tuberculosis infection, with 2 blood tests which have recently become commercially available (Interferon-gamma release assays) in a population of immunosuppressed individuals with chronic renal failure undergoing long term hemodialysis
Detailed description
This prospective study includes all adults aged over 18 years of age who accept to be included in the study and provided written informed consent. All patients are under long term hemodialysis for chronic renal failure. They are subjected to a questionnaire including history of contacts with tuberculosis (TB), prior treatment for TB, history of prior tuberculin skin testing, history of BCG vaccination, country of origin, trips or prolonged stays in high incidence areas, smoking history, and medications. All patients will have a chest X-ray, and simultaneous testing with the tuberculin skin test according to the Mantoux technique, and with the T-SPOT. TB and QuantiFERON Gold in tube Interferon-gamma release assays. The study analysis agreement between tests, detection of prior TB and presumptive latent tuberculosis infection, based on these items.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis | – | –Patients under chronic hemodialysis for chronic end stage renal failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged over 18 Under hemodialysis for > 3 months End stage renal failure
Key inclusion criteria (3 listed)
- Adults aged over 18
- Under hemodialysis for > 3 months
- End stage renal failure
Key exclusion criteria (2 listed)
- Refusal to participate
- Prior tuberculin skin test > 15 mm or any adverse reaction to tuberculin skin test
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
Relative performance of tuberculin skin test and interferon gamma release assays for detecting latent tuberculosis infection
Time frame: cross-sectionnal
1 secondary outcome
Agreement between tuberculin skin test and interferon gamma release assays as well as agreement between interferon gamma release assays
Time frame: cross-sectionnal
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 12 Jun 2008.
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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.
Jean-Paul Janssens, MD principal investigator
University Hospital, Geneva
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 Chronic Renal Failure, run by University Hospital, Geneva at 1 site in Switzerland.
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 3 inclusion and 2 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 12 Jun 2008. 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 Switzerland. 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?
Relative performance of tuberculin skin test and interferon gamma release assays for detecting latent tuberculosis infection (time frame: cross-sectionnal). 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 12 Jun 2008.