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NCT Number: NCT06829719

TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation

Long-term outcomes in kidney transplantation remain a significant challenge, as complications such as donor-specific antibodies (DSA), antibody-mediated rejection, infections, and cancer increasingly threaten graft and patient survival over time. The development of non-invasive biomarkers to guide the management of therapeutic immunosuppression beyond the first year post-transplantation is therefore a crucial unmet need.

Torque Teno Virus (TTV), a non-pathogenic virus with a high prevalence worldwide, has emerged as a promising biomarker in this context. Its replication inversely reflects immune control by T cells, correlating with the depth of therapeutic immunosuppression. Additionally, its slow replication kinetics make TTV DNAemia a useful marker for evaluating patient adherence to immunosuppressive treatments.

The TAOIST study tests whether longitudinal monitoring of TTV DNAemia every six months, starting from the second year after transplantation, can guide the personalization of immunosuppressive therapy. The primary endpoint is the time to the first occurrence of complications linked to inadequate immunosuppression, including dnDSA, biopsy-proven rejection, infection, cancer, or graft loss. Secondary objectives include evaluating the acceptability of TTV DNAemia among healthcare professionals and assessing its cost-effectiveness compared to standard care. An ancillary objective examines the link between TTV DNAemia and the immunosuppressant possession ratio (IPR) to explore its potential as a marker of treatment adherence.

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Key information

Conditions

Infection Behavior Cancer Infections Kidney Transplantation Neoplasms Rejection Rejection, Psychology Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Néphrologie-Transplantation-Dialyse I Hôpital Pellegrin I - CHU Bordeaux, Bordeaux (France), France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult ≥ 18 years-old
  • Recipient of a kidney allograft (third graft at most)
  • 12 to 48 months post-transplantation
  • Stable graft function (defined as: delta creatininemia over the previous 6 months < 20% and proteinuria < 30mg/mmol)
  • On maintenance immunosuppression, which includes CNI (cyclosporin or tacrolimus) and MMF (Cellcept or Myfortic) with or without corticosteroids
  • Detectable TTV DNAemia at enrollment
  • No circulating DSA in solid phase assay
  • Undetectable BKV DNAemia at enrollment
  • Written informed consent

Exclusion criteria

  • Recipient of an HLA identical graft
  • Mutiple organ transplantation or functional transplant other than kidney
  • Maintenance immunosuppression that includes a mTOR inhibitor, belatacept or imurel
  • Presence of histological sign of active rejection (i+t > 2 and g+cpt > 2) on graft biopsy performed within 3 months before enrollment
  • Uncontrolled infection at inclusion
  • Infection requiring hospitalization within 3 months before inclusion
  • Diagnosis of a cancer of interest between the (current) transplantation and inclusion
  • Pregnant, unwillingness to practice adequate contraception or patient with a pregnancy plan during 3 years of study
  • Person not affiliated to a social security scheme or beneficiary of a similar scheme
  • Person subject to a legal protection measure (guardianship, curatorship) or deprived of liberty

Treatment and study plan

TTV DNAemia

Biological

Every 6 months, one sample added at the same time (7mL) of a routine laboratory analysis for TTV DNAemia

EQ-5D-5L questionnaire

Other

Completed every 6 months and each time a complication of interest occurs

Biological tests

Biological

Biological tests as routine care procedure (creatinine, CNI pre-dose trough level) will be performed every 6 months

Primary outcomes

  1. Compare the time from randomization to first complication of inadequate immunosuppression between the experimental group, whose treatment is tailored on quarterly TTV viral load results, and the control group.

    Time frame: through study completion, an average of 6 years

    Time from randomization to occurrence of the first complication of inadequate immunosuppression: development of dnDSA, biopsy-proven rejection, infection, cancer, graft loss. Patients lost to follow-up or died without an event before will be right censored at this date.

Secondary outcomes

  1. Proportion of patients with at least one complication of inadequate immunosuppression between the experimental and control groups at 36 months

    Time frame: through study completion, an average of 6 years

    Percentage of patients with at least one complication of inadequate immunosuppression during the 36 months of follow-up.

  2. Compare the rate of complications of inadequate immunosuppression between patients in the experimental and control groups.

    Time frame: through study completion, an average of 6 years

    Number of complications of inadequate immunosuppression/patient/month of follow-up

  3. Describe the nature and timing of various complications of inadequate immunosuppression in the experimental and control groups.

    Time frame: through study completion, an average of 6 years

    Percentage of patients (at 36 months) and time to first complication for each of the complications of interest: development of dnDSA, biopsy-proven rejection, infection, cancer, graft loss.

  4. Compare the proportion of patients with adequate immunosuppressive therapy between the experimental and control groups.

    Time frame: through study completion, an average of 6 years

    Percentage of patients with TTV viral load between 3.8 and 5.1 log cp/ml at the majority (>6/12) of quarterly routine controls.

  5. Compare the proportion of quarterly systematic checks of TTV DNAemia in the target between patients in the experimental and control groups.

    Time frame: Every 6 months

    Percentage of quarterly routine TTV viral load tests between 3.8 and 5.1 log cp/ml.

  6. Model the impact of variations in dose and residual rates (pre-dose trough levels or AUC) of the various immunosuppressive drugs on TTV viral load.

    Time frame: every 6 months

    Joint analysis of the evolution of dose variations, residual immunosuppression rates of immunosuppressive drugs and TTV viral load.

  7. Evaluate how nephrologists and biologists feel about using the new test in clinical practice.

    Time frame: 6th year

    Questionnaires specific to each sub-populations (nephrologists and biologists) using open-ended questions and Likert scale-coded responses.

  8. Assess the cost-effectiveness of the intervention compared to standard care at 36 months from the French Health care System perspective

    Time frame: through study completion, an average of 6 years

    Cost-effectiveness ratio (ICER) is defined as the difference in cost between the intervention and the standard care, divided by the difference in their effect (QALY).

Study contacts

Contact information is provided by the study sponsor or research team.

Olivier THAUNAT, Professor MD, PhD

CONTACT

[email protected]

+334.72.11.69.28

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Collaborators

  • BioMérieux

Registry information

Official study title

Personalization of Maintenance Immunosuppression Based on TTV Viral Load to Prevent Long-term Complications in Renal Transplantation

Acronym: TAOIST

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Feb 17, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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