Kidney Transplant InfectionPTTKTNCT05249699
The Prophylaxis of Tuberculosis According to TSPOT Results After Kidney Transplantation
A study testing Isoniazid and without any additional anti-tuberculosis treatment in people with Kidney Transplant Infection and Tuberculosis, run by West China Hospital.
Trial summary
Organ transplant recipients are a high incidence group of tuberculosis infection, and the incidence rate is 7-27 times that of the general population. The prevention of postoperative tuberculosis infection is an important part of kidney transplant recipients postoperative follow-up. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplant Infection, Tuberculosis, Isoniazid Toxicity
- What is being tested?
- Isoniazid and without any additional anti-tuberculosis treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Aug 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- living-donor kidney transplantation;
- eGFR level > 45ml/min/1.73m2 at discharge;
- 18<Age <65years;
- receiving standard triad immunosuppressive regimen
Who cannot join
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 or more of upper limit of normal
- Combined with HBV/HCV/HIV/TB infection in the donor or recipient;
- Malignancy history in the donor and recipient;
- organ transplant history in the recipient.
- The positive TSPOT result or past TB history in the donor
About this study
Official title: The Prophylaxis of Tuberculosis According to TSPOT Results After Kidney Transplantation (PTTKT):Protocol for an Open-label, Prospective, Randomized, 3-arm, Controlled Trial
Organ transplant recipients are a high incidence group of tuberculosis infection, and the incidence rate is 7-27 times that of the general population. The prevention of postoperative tuberculosis infection is an important part of kidney transplant recipients postoperative follow-up. Taking reasonable tuberculosis prevention strategies for organ transplant recipients can better prevent the occurrence of postoperative tuberculosis and reduce the unreasonable use of anti-tuberculosis drugs. The previous screening methods for active tuberculosis mainly include sputum smear culture, tissue biopsy, tuberculin skin test, tuberculosis antibody, tuberculosis DNA, and chest imaging. However, there is still a lack of accurate and effective means for screening for latent tuberculosis infection. The tuberculosis interferon-γ release test has recently received more and more attention as a means of screening for potential tuberculosis infection. However, how to apply tuberculosis interferon-γ release test in clinical practice is still controversial. The investigators hope to explore the clinical application prospects and practical value of tuberculosis interferon-γ release test through this research.
According to the conclusion of the retrospective study, the investigators found that the recipients with negative TSPOT result maybe don't need follow the isoniazid treatment to prevent the development of tuberculosis even though participants have clinical risk factor of tuberculosis(include past tuberculosis history, the close contact with active tuberculosis patients, an area with a high incidence of tuberculosis, abnormal chest x ray performance ).
The investigators will divided the recipients with tuberculosis risk factors into three groups randomly. Of course, the invention require written informed consent. The first group with positive tuberculosis interferon gamma release assay (TSPOT) result will follow through with the treatment ,which is a daily dose of isoniazid for six months(300mg daily) after kidney transplant surgery. The second group with negative TSPOT result will not follow through the isoniazid treatment. The third group will follow through with the isoniazid treatment no matter their TSPOT results. The investigators will conduct a prospective clinical trial with the first aim of exploring the effectiveness of TSPOT results in kidney transplant recipients with clinical tuberculosis risk factors, and the second aim of exploring the benefit of the isoniazid treatment follow the TSPOT results rather than clinical risk factors.
- Being tested
- Isoniazid, without any additional anti-tuberculosis treatment
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoniazidDrug
prevent the development of tuberculosis
without any additional anti-tuberculosis treatmentOther
reduce the number of Participants With Treatment-Related Adverse Events
| Study group | Role | What they receive |
|---|---|---|
| Positive TSPOT results with clinical risk factors group | Experimental | patients receive isoniazid 300mg once daily for six months after kidney transplant surgery form discharge Receives: Drug: Isoniazid |
| Negative TSPOT results with clinical risk factors group | Placebo comparator | patients receive no additional therapy Receives: Other: without any additional anti-tuberculosis treatment |
| Clinical risk factors group | Experimental | patients receive isoniazid 300mg once daily for six months after kidney transplant surgery form discharge Receives: Drug: Isoniazid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the incidence of tuberculosis in these groups.
The primary objective of this study is to evaluate the incidence of tuberculosis between these groups. The incidence of tuberculosis was assessed by WHO TB guidelines 2021.
Measured: 12 months
Secondary outcomes (1)
The secondary outcome is subject incidence of adverse events
The primary objective of this study is to evaluate the safety of isoniazide among the kidney transplant recipients
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant InfectionStudies of the same condition, open and under way.
- More trials run by West China 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Lin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249699
- Sponsor's protocol ID
- WestChinaH-PTTKT
- Acronym
- PTTKT
- Status last verified
- Mar 2022
- First submitted
- 19 Oct 2021
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim H, Kim SH, Jung JH, Kim MJ, Kim H, Shin S, Chong YP, Kim YH, Lee SO, Choi SH, Kim YS, Woo JH, Park SK, Han DJ. The usefulness of quantitative interferon-gamma releasing assay response for predicting active tuberculosis in kidney transplant recipients: A quasi-experimental study. J Infect. 2020 Sep;81(3):403-410. doi: 10.1016/j.jinf.2020.06.070. Epub 2020 Jun 29.
PubMed 32610111Shu CC, Tsai MK, Lin SW, Wang JY, Yu CJ, Lee CY. Latent Tuberculosis Infection Increases in Kidney Transplantation Recipients Compared With Transplantation Candidates: A Neglected Perspective in Tuberculosis Control. Clin Infect Dis. 2020 Aug 14;71(4):914-923. doi: 10.1093/cid/ciz851.
PubMed 32620949Kim SH, Lee SO, Park IA, Kim SM, Park SJ, Yun SC, Jung JH, Shin S, Kim YH, Choi SH, Kim YS, Woo JH, Park SK, Park JS, Han DJ. Isoniazid treatment to prevent TB in kidney and pancreas transplant recipients based on an interferon-gamma-releasing assay: an exploratory randomized controlled trial. J Antimicrob Chemother. 2015 May;70(5):1567-72. doi: 10.1093/jac/dku562. Epub 2015 Jan 20.
PubMed 25608587Kim SH, Lee SO, Park JB, Park IA, Park SJ, Yun SC, Jung JH, Kim YH, Kim SC, Choi SH, Jeong JY, Kim YS, Woo JH, Park SK, Park JS, Han DJ. A prospective longitudinal study evaluating the usefulness of a T-cell-based assay for latent tuberculosis infection in kidney transplant recipients. Am J Transplant. 2011 Sep;11(9):1927-35. doi: 10.1111/j.1600-6143.2011.03625.x. Epub 2011 Jul 12.
PubMed 21749641
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prophylaxis of Tuberculosis According to TSPOT Results After Kidney Transplantation (PTTKT):Protocol for an Open-label, Prospective, Randomized, 3-arm, Controlled Trial
- ClinicalTrials.gov ID
- NCT05249699
- Acronym / sponsor ID
- PTTKT / WestChinaH-PTTKT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 303 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 22 Feb 2022 (actual)
- 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.
Organ transplant recipients are a high incidence group of tuberculosis infection, and the incidence rate is 7-27 times that of the general population. The prevention of postoperative tuberculosis infection is an important part of kidney transplant recipients postoperative follow-up. Taking reasonable tuberculosis prevention strategies for organ transplant recipients can better prevent the occurrence of postoperative tuberculosis and reduce the unreasonable use of anti-tuberculosis drugs. The previous screening methods for active tuberculosis mainly include sputum smear culture, tissue biopsy, tuberculin skin test, tuberculosis antibody, tuberculosis DNA, and chest imaging. However, there is still a lack of accurate and effective means for screening for latent tuberculosis infection. The tuberculosis interferon-γ release test has recently received more and more attention as a means of screening for potential tuberculosis infection. However, how to apply tuberculosis interferon-γ release test in clinical practice is still controversial. The investigators hope to explore the clinical application prospects and practical value of tuberculosis interferon-γ release test through this research.
According to the conclusion of the retrospective study, the investigators found that the recipients with negative TSPOT result maybe don't need follow the isoniazid treatment to prevent the development of tuberculosis even though participants have clinical risk factor of tuberculosis(include past tuberculosis history, the close contact with active tuberculosis patients, an area with a high incidence of tuberculosis, abnormal chest x ray performance ).
The investigators will divided the recipients with tuberculosis risk factors into three groups randomly. Of course, the invention require written informed consent. The first group with positive tuberculosis interferon gamma release assay (TSPOT) result will follow through with the treatment ,which is a daily dose of isoniazid for six months(300mg daily) after kidney transplant surgery. The second group with negative TSPOT result will not follow through the isoniazid treatment. The third group will follow through with the isoniazid treatment no matter their TSPOT results. The investigators will conduct a prospective clinical trial with the first aim of exploring the effectiveness of TSPOT results in kidney transplant recipients with clinical tuberculosis risk factors, and the second aim of exploring the benefit of the isoniazid treatment follow the TSPOT results rather than clinical risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive TSPOT results with clinical risk factors group | Experimental | Drug: Isoniazidpatients receive isoniazid 300mg once daily for six months after kidney transplant surgery form discharge |
| Negative TSPOT results with clinical risk factors group | Placebo comparator | Other: without any additional anti-tuberculosis treatmentpatients receive no additional therapy |
| Clinical risk factors group | Experimental | Drug: Isoniazidpatients receive isoniazid 300mg once daily for six months after kidney transplant surgery form discharge |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- living-donor kidney transplantation;
- eGFR level > 45ml/min/1.73m2 at discharge;
- 18<Age <65years;
- receiving standard triad immunosuppressive regimen
Key exclusion criteria (5 listed)
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 or more of upper limit of normal
- Combined with HBV/HCV/HIV/TB infection in the donor or recipient;
- Malignancy history in the donor and recipient;
- organ transplant history in the recipient.
- The positive TSPOT result or past TB history in the donor
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 |
|---|---|---|
| Isoniazidprevent the development of tuberculosis | Drug | Clinical risk factors group, Positive TSPOT results with clinical risk factors group |
| without any additional anti-tuberculosis treatmentreduce the number of Participants With Treatment-Related Adverse Events | Other | Negative TSPOT results with clinical risk factors group |
Primary outcome
The primary outcome is the incidence of tuberculosis in these groups.
Time frame: 12 months
The primary objective of this study is to evaluate the incidence of tuberculosis between these groups. The incidence of tuberculosis was assessed by WHO TB guidelines 2021.
1 secondary outcome
The secondary outcome is subject incidence of adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Background: PubMed 32610111Kim H, Kim SH, Jung JH, Kim MJ, Kim H, Shin S, Chong YP, Kim YH, Lee SO, Choi SH, Kim YS, Woo JH, Park SK, Han DJ. The usefulness of quantitative interferon-gamma releasing assay response for predicting active tuberculosis in kidney transplant recipients: A quasi-experimental study. J Infect. 2020 Sep;81(3):403-410. doi: 10.1016/j.jinf.2020.06.070. Epub 2020 Jun 29.
- Background: PubMed 32620949Shu CC, Tsai MK, Lin SW, Wang JY, Yu CJ, Lee CY. Latent Tuberculosis Infection Increases in Kidney Transplantation Recipients Compared With Transplantation Candidates: A Neglected Perspective in Tuberculosis Control. Clin Infect Dis. 2020 Aug 14;71(4):914-923. doi: 10.1093/cid/ciz851.
- Background: PubMed 25608587Kim SH, Lee SO, Park IA, Kim SM, Park SJ, Yun SC, Jung JH, Shin S, Kim YH, Choi SH, Kim YS, Woo JH, Park SK, Park JS, Han DJ. Isoniazid treatment to prevent TB in kidney and pancreas transplant recipients based on an interferon-gamma-releasing assay: an exploratory randomized controlled trial. J Antimicrob Chemother. 2015 May;70(5):1567-72. doi: 10.1093/jac/dku562. Epub 2015 Jan 20.
- Background: PubMed 21749641Kim SH, Lee SO, Park JB, Park IA, Park SJ, Yun SC, Jung JH, Kim YH, Kim SC, Choi SH, Jeong JY, Kim YS, Woo JH, Park SK, Park JS, Han DJ. A prospective longitudinal study evaluating the usefulness of a T-cell-based assay for latent tuberculosis infection in kidney transplant recipients. Am J Transplant. 2011 Sep;11(9):1927-35. doi: 10.1111/j.1600-6143.2011.03625.x. Epub 2011 Jul 12.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Isoniazid and without any additional anti-tuberculosis treatment in people with Kidney Transplant Infection and Tuberculosis, run by West China Hospital.
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 4 inclusion and 5 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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The primary outcome is the incidence of tuberculosis in these groups. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05249699, which also lists 4 linked publications.
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 Apr 2022.