NCT05836636: TTV-KTR-SGH

Immune Monitoring of Prevalent Kidney Transplant Recipients Using Torque Teno Virus: A Single-Center, Prospective Cohort Study

Active, enrolled Last updated 18 May 2025

What this trial tests

trial testing Torque teno virus DNA measurement in Kidney Transplant Infection in 172 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

27 June 2023

Primary endpoint
31 July 2025

31 July 2025

Quick facts

Lead sponsor	Singapore General Hospital
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	172
Start date	27 June 2023
Primary completion	31 July 2025
Estimated completion	31 July 2025
Sites	1 location across Singapore

Drugs / interventions tested

• Torque teno virus DNA measurement

Conditions studied

• Kidney Transplant Infection — all drugs for Kidney Transplant Infection →
• Kidney Transplant Rejection — all drugs for Kidney Transplant Rejection →
• Kidney Transplant; Complications — all drugs for Kidney Transplant; Complications →

Sponsor

Singapore General Hospital

Who can join

Adults 21 to 99, any sex, with Kidney Transplant Infection or Kidney Transplant Rejection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Immune monitoring of prevalent kidney transplant recipients using Torque Teno Virus: Protocol for a single-centre prospective cohort study.
   Ho QY, Lai CMD, Liew IT, Oon LLE, et al · · 2023 · PMID 37730403 · DOI 10.1136/bmjopen-2023-076122