Kidney TransplantationNCT02782416
Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Kidney Transplantation
A study testing Examination of latent tuberculosis in people with Kidney Transplantation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the incidence of active TB Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Examination of latent tuberculosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to Dec 2017
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-65 and match one of below
- Waiting renal transplant or status post renal transplant
- Receiving long term dialysis
Who cannot join
- Not agree to be enrolled
- Suspected active TB
- HIV patients
- Viral hepatitis
- Using immunosuppressants within 3 months before enrollment
- Receiving lymphokine therapy
Show all 10Show fewer
- Hemoglobin < 8 g/dL
- Serum bilirubin > 2.5 mg/dL
- AST or ALT > 2 times of upper normal limit
- Lactation or pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chin-Chung Shu, MD, +886972653087, ccshu139@ntu.edu.tw
About this study
Official title: A Randomized Study for Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Patients Preparing for Kidney Transplantation
Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the incidence of active TB
Read the detailed description
Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the incidence of active TB
- Conditions
- Kidney Transplantation
- Being tested
- Examination of latent tuberculosis
- Keywords
- Renal, Latent, Tuberculosis
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination of latent tuberculosisOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Examination of latent tuberculosis |
| Status post renal transplant | Other | patients who have received renal transplant Receives: 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 Receives: Other: Examination of latent tuberculosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of active TB
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
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
- NCT02782416
- Sponsor's protocol ID
- 201309056RINC
- Status last verified
- Dec 2016
- First submitted
- 11 May 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study for Screening Latent Tuberculosis Infection and Observing Preventive Therapy in Patients Preparing for Kidney Transplantation
- ClinicalTrials.gov ID
- NCT02782416
- Acronym / sponsor ID
- 201309056RINC
- Conditions
- Kidney Transplantation
- Keywords
- Renal, Latent, Tuberculosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 May 2016 (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.
Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the incidence of active TB
Detailed description
Study the prevalence of LTBI in patients who are waiting renal transplant and monitor the incidence of active TB
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Examination of latent tuberculosisDialysis patients who are not waiting for renal transplant |
| Status post renal transplant | Other | Other: Examination of latent tuberculosispatients who have received renal transplant |
| Waiting for renal transplant_ screening of LTBI | Experimental | Other: Examination of latent tuberculosispatients with renal failure and are waiting for renal transplant We do routine examination in addition to LTBI check |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20-65 and match one of below
- Waiting renal transplant or status post renal transplant
- Receiving long term dialysis
Key exclusion criteria (10 listed)
- Not agree to be enrolled
- Suspected active TB
- HIV patients
- Viral hepatitis
- Using immunosuppressants within 3 months before enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Examination of latent tuberculosis | Other | Not waiting for renal transplant, Status post renal transplant, Waiting for renal transplant_ screening of LTBI |
Primary outcome
percentage of active TB
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Individual participant dataSharing planned: No
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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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.
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?
A study testing Examination of latent tuberculosis in people with Kidney Transplantation, 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Dec 2016. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chin-Chung Shu, MD (+886972653087, ccshu139@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of active TB (time frame: 4 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 15 Dec 2016.