Kidney Transplant InfectionTTV-KTR-SGHNCT05836636
Immune Monitoring of Prevalent Kidney Transplant Recipients Using Torque Teno Virus: A Single-Center, Prospective Cohort Study
An observational study of Kidney Transplant Infection and Kidney Transplant Rejection, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Kidney transplant recipients (KTRs) suffer from immunosuppression-related adverse events (iRAEs), such as infections and malignancy from chronic immunosuppression exposure but are also at risk of graft loss from rejection with under-immunosuppression. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Kidney Transplant Infection, Kidney Transplant Rejection, Kidney Transplant; Complications
- What is being tested?
- Torque teno virus DNA measurement
- How many people
- 172 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Jun 2023to 31 Jul 2025
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney transplant recipients (KTRs) on stable doses of immunosuppression for more than 3 months
Who may be able to join
- Kidney transplant recipients on follow up at Singapore General Hospital (SGH)
- More than 21 years old
- On stable doses of immunosuppression for more than 3 months
Who cannot join
- Titration of immunosuppression (e.g. for rejection or infection) less than 3 months ago
- Active infection requiring treatment
- Less than 21 years old
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Kidney transplant recipients (KTRs) suffer from immunosuppression-related adverse events (iRAEs), such as infections and malignancy from chronic immunosuppression exposure but are also at risk of graft loss from rejection with under-immunosuppression. Biomarkers that predict both iRAEs and rejection and allow individualisation of immunosuppression exposure are lacking. While plasma viral DNA levels of Torque Teno Virus (TTV), a widely prevalent, non-pathogenic virus, have been shown to predict both iRAE and rejection in incident KTRs within 1 year after transplant, its role for prevalent KTRs on stable immunosuppression is unclear.
The investigators hypothesise that plasma TTV levels can predict iRAEs and rejection in KTRs on stable immunosuppression and propose a pilot study to pursue three specific aims: (1) To determine the TTV levels and its relationship with clinical factors affecting the 'net state of immunosuppression' in prevalent KTRs. (2) To analyse the prognostic value of TTV levels for iRAEs and rejection in prevalent KTRs. (3) To compare the prognostic performance of TTV levels to commonly available biomarkers and composite prognostic scores.
Read more
The investigators seek pursue these aims by performing a single-centre, prospective, observational cohort study of 172 KTRs on stable immunosuppression for more than 3 months. TTV levels will be measured, using the TTV R-GENE® kit, upon recruitment and when kidney allograft biopsies are performed. Subjects will be monitored for iRAEs and rejection for at least 12 months.
The study will provide data on the distribution of TTV levels in a prevalent cohort of KTRs and analyse its relationship with clinical factors and important clinical outcomes. If the study indicates that TTV may be predictive of iRAEs and rejection, the investigators aim to conduct further studies including interventional studies using TTV levels to guide immunosuppression. Ultimately, the investigators aim to use TTV as a biomarker to optimise long-term immunosuppression exposure, reduce the risk of iRAEs without increase in rejection, and improve long-term outcomes for KTRs.
- Conditions
- Kidney Transplant Infection, Kidney Transplant Rejection, Kidney Transplant; Complications
- Being tested
- Torque teno virus DNA measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torque teno virus DNA measurementOther
Torque teno virus DNA level will be obtained from all study subjects upon recruitment, when subjects are admitted and when subjects undergo kidney allograft biopsies.
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe infections defined as any infection requiring hospitalization
Any infection requiring hospitalization
Measured: 1 year
Secondary outcomes (10)
Opportunistic infections
intracellular bacteria, mycobacteria, Listeria monocytogenes, and Nocardia spp., herpesviruses (CMV, HSV, and VZV), polyomaviruses, yeasts (Candida and Cryptococcus), molds (invasive aspergillosis and mucormycosis), and parasites (Toxoplasma gondii, PJP, and Leishmania)
Measured: 1 year
De novo malignancy
De novo malignancy
Measured: 1 year
Calcineurin inhibitor nephrotoxicity (biopsy-proven)
Calcineurin inhibitor nephrotoxicity (biopsy-proven)
Measured: 1 year
Rejection (biopsy-proven)
With and without borderline T cell-mediated rejection
Measured: 1 year
Glomerulonephritis - de novo or recurrent (biopsy-proven)
Measured: 1 year
Graft function
serum creatinine, estimated glomerular filtration rate by the CKD-EPI equation and urine protein-to-creatinine ratio
Measured: 1 year
Graft loss
Censored and non-censored for death
Measured: 1 year
Mortality
All-cause and cause-specific - i.e., infection, malignancy, cardiovascular, others
Measured: 1 year
Immunosuppression-related adverse event
Composite outcome of severe infections defined as any infection requiring hospitalization, opportunistic infections, de novo malignancy and calcineurin inhibitor nephrotoxicity
Measured: 1 year
Immune-mediated adverse event
Composite outcome of rejection (biopsy-proven) and glomerulonephritis (biopsy-proven)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start27 Jun 2023
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Singapore General 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836636
- Sponsor's protocol ID
- 2023/2170
- Acronym
- TTV-KTR-SGH
- Status last verified
- May 2025
- First submitted
- 19 Apr 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ho QY, Lai CMD, Liew IT, Oon LLE, Lim KL, Chung SJ, Thangaraju S, Tien SC, Tan CS, Kee T. Immune monitoring of prevalent kidney transplant recipients using Torque Teno Virus: Protocol for a single-centre prospective cohort study. BMJ Open. 2023 Sep 19;13(9):e076122. doi: 10.1136/bmjopen-2023-076122.
PubMed 37730403
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Monitoring of Prevalent Kidney Transplant Recipients Using Torque Teno Virus: A Single-Center, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05836636
- Acronym / sponsor ID
- TTV-KTR-SGH / 2023/2170
- Conditions
- Kidney Transplant Infection, Kidney Transplant Rejection, Kidney Transplant; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 1 May 2023 (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.
Kidney transplant recipients (KTRs) suffer from immunosuppression-related adverse events (iRAEs), such as infections and malignancy from chronic immunosuppression exposure but are also at risk of graft loss from rejection with under-immunosuppression. Biomarkers that predict both iRAEs and rejection and allow individualisation of immunosuppression exposure are lacking. While plasma viral DNA levels of Torque Teno Virus (TTV), a widely prevalent, non-pathogenic virus, have been shown to predict both iRAE and rejection in incident KTRs within 1 year after transplant, its role for prevalent KTRs on stable immunosuppression is unclear.
The investigators hypothesise that plasma TTV levels can predict iRAEs and rejection in KTRs on stable immunosuppression and propose a pilot study to pursue three specific aims: (1) To determine the TTV levels and its relationship with clinical factors affecting the 'net state of immunosuppression' in prevalent KTRs. (2) To analyse the prognostic value of TTV levels for iRAEs and rejection in prevalent KTRs. (3) To compare the prognostic performance of TTV levels to commonly available biomarkers and composite prognostic scores.
The investigators seek pursue these aims by performing a single-centre, prospective, observational cohort study of 172 KTRs on stable immunosuppression for more than 3 months. TTV levels will be measured, using the TTV R-GENE® kit, upon recruitment and when kidney allograft biopsies are performed. Subjects will be monitored for iRAEs and rejection for at least 12 months.
The study will provide data on the distribution of TTV levels in a prevalent cohort of KTRs and analyse its relationship with clinical factors and important clinical outcomes. If the study indicates that TTV may be predictive of iRAEs and rejection, the investigators aim to conduct further studies including interventional studies using TTV levels to guide immunosuppression. Ultimately, the investigators aim to use TTV as a biomarker to optimise long-term immunosuppression exposure, reduce the risk of iRAEs without increase in rejection, and improve long-term outcomes for KTRs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients (KTRs) on stable doses of immunosuppression for more than 3 months
Key inclusion criteria (3 listed)
- Kidney transplant recipients on follow up at Singapore General Hospital (SGH)
- More than 21 years old
- On stable doses of immunosuppression for more than 3 months
Key exclusion criteria (4 listed)
- Titration of immunosuppression (e.g. for rejection or infection) less than 3 months ago
- Active infection requiring treatment
- Less than 21 years old
- Unable to provide informed consent
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 |
|---|---|---|
| Torque teno virus DNA measurementTorque teno virus DNA level will be obtained from all study subjects upon recruitment, when subjects are admitted and when subjects undergo kidney allograft biopsies. | Other | – |
Primary outcome
Severe infections defined as any infection requiring hospitalization
Time frame: 1 year
Any infection requiring hospitalization
10 secondary outcomes
Opportunistic infections
Time frame: 1 year
De novo malignancy
Time frame: 1 year
Calcineurin inhibitor nephrotoxicity (biopsy-proven)
Time frame: 1 year
Rejection (biopsy-proven)
Time frame: 1 year
Glomerulonephritis - de novo or recurrent (biopsy-proven)
Time frame: 1 year
Graft function
Time frame: 1 year
Graft loss
Time frame: 1 year
Mortality
Time frame: 1 year
Immunosuppression-related adverse event
Time frame: 1 year
Immune-mediated adverse event
Time frame: 1 year
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 29 Apr 2026.
- Derived from this study: PubMed 37730403Ho QY, Lai CMD, Liew IT, Oon LLE, Lim KL, Chung SJ, Thangaraju S, Tien SC, Tan CS, Kee T. Immune monitoring of prevalent kidney transplant recipients using Torque Teno Virus: Protocol for a single-centre prospective cohort study. BMJ Open. 2023 Sep 19;13(9):e076122. doi: 10.1136/bmjopen-2023-076122.
- Individual participant dataSharing planned: Yes
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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.
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 Kidney Transplant Infection and Kidney Transplant Rejection, run by Singapore General Hospital at 1 site in Singapore.
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 4 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 29 Apr 2026. 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 Singapore. 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?
Severe infections defined as any infection requiring hospitalization (time frame: 1 year). 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 NCT05836636, which also lists 1 linked publication.
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 29 Apr 2026.