Torque Teno Virus: A Biomarker of Immunosuppression

Torque Teno Virus: A Biomarker of Immunosuppression in Kidney Transplantation, an Observational Single Centre Study

To seek an association between Torque Teno Virus DNA titres resulting from under or over-immunosuppression in a kidney allograft recipient, Graft rejection, both cell-mediated rejection and antibody-mediated rejection, donor-specific antibodies (DSA), the incidence of BK viraemia and BK nephropathy, CMV infection or diseases and PCP infection and the number of circulating NK, B and T lymphocyte subtypes.

Study Overview

• Status: Completed
• Conditions: Immunosuppression; Renal Transplant Rejection; Renal Transplant Failure; Renal Transplant Infection
• Intervention / Treatment: Other: None Observational study

Detailed Description

Balancing the adverse effects of over-immunosuppression such as infection and malignancy, to the risk of rejection, remains the central challenge for day-to-day clinical practice in transplantation. A quantitative measure of immunocompetence remains elusive, and in the absence of such markers, immunosuppression drug concentrations and clinical events, such as organ rejection, infection, malignancy etc. are used as surrogate markers of immunocompetence to guide therapy. As demonstrated in several studies, the Torque teno virus is widespread amongst the general population. In theory, if one suppresses the immune system, these viruses should multiply, resulting in a higher DNA level which can be detected by a simple blood test. Hence, the DNA level could be used as an indicator for the level of immunosuppression, along with the available blood tests to measure the level of toxicity of the said drugs.

In this research to be done at the Royal London Hospital, the investigators aim to elucidate that the Torque teno virus is widely prevalent in an ethnically diverse East London kidney transplant recipient population by conducting the viral PCR on blood samples already collected during their routine clinic visits. The population will include all kidney transplant recipients in a two-year period. The investigators will measure the correlation between the TTV DNA level and drug concentrations of the immunosuppressive medications which will elucidate how the DNA levels are affected by different drug concentrations. The investigators will then measure the correlation between the TTV DNA levels, and the common adverse outcomes experienced by the transplant recipients, namely, patient death, loss of transplant organs, transplant rejection, rates of infection, and cancers in transplant patients by collecting data from patient records. These tests will help understand whether the Torque teno virus DNA levels can be used as a marker of immunosuppression in the general population in the UK.

• Study Type: Observational
• Enrollment (Actual): 268

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW4 8FA
    • Royal London Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All consenting renal transplant recipients in the study period

Description

Inclusion Criteria:

• All consenting renal transplant recipients in the study period will be included in the study

Exclusion Criteria:

• no exclusion criteria.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Renal transplant recipients; All incident renal transplant recipients after the commencement of the study	Other: None Observational study; Non interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The correlation between TTV viral load and Biopsy proven graft rejection	6 months

Collaborators and Investigators

• Sponsor: Queen Mary University of London

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): August 31, 2025
• Study Completion (Actual): August 31, 2025

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: immunosuppression; renal transplant; Torque teno virus
• Other Study ID Numbers: 291391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No