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

NCT05836636 | Completed

• 1 other identifier: 2023/2170
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Kidney Transplant Rejection; Kidney Transplant; Complications; Kidney Transplant Infection

Outcome Measures

Primary Outcomes (1)

• Severe infections defined as any infection requiring hospitalization

  Any infection requiring hospitalization

  1 year

Secondary Outcomes (10)

• Opportunistic infections

  1 year

• De novo malignancy

  1 year

• Calcineurin inhibitor nephrotoxicity (biopsy-proven)

  1 year

• Rejection (biopsy-proven)

  1 year

• Glomerulonephritis - de novo or recurrent (biopsy-proven)

  1 year

Interventions

Torque teno virus DNA measurement OTHER

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.

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Kidney transplant recipients (KTRs) on stable doses of immunosuppression for more than 3 months

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, Singapore, 767972, Singapore

Location

Related Publications (1)

• 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.

  PMID: 37730403 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: June 27, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: April 29, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

SG (1)