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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-23

Study Completion Date

2031-02-02

Brief Summary

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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 three 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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Detailed Description

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Conditions

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Infection Cancer Rejection Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, interventional, multicentric, open-label, parallel group, superiority randomized controlled trial.

Kidney transplant recipients from the 4 enrollment centers will be randomly assigned with a 1:1 allocation into experimental and control groups between 12- and 48-months post-transplantation, and prospectively followed for 36 months for the occurrence of a complication due to inadequate (over or under) immunosuppression.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

TTV DNAemia will be measured every 3 months for all patients but the results will not be communicated to the physicians for patients from the control group.

Study Groups

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TTV-guided immunosuppression

The adaptation of the dose of maintenance immunosuppressive drugs will be based on TTV DNAemia measured on site in the plasma of patients every 3 months (at distance of an infection or a vaccination). The physicians will be free to change the dose of calcineurin inhibitors (CNI) and/or the mycophenolate mofetil (MMF) to maintain TTV DNAemia between 3.8 and 5.1 log10 cp/mL as long as the trough levels remain between 3-12 ng/mL for tacrolimus (50-250 ng/mL for cyclosporin) and the daily dose of MMF is comprise between 250 and 1500 mg bid for Cellcept (180 and 900 mg for Myfortic).

Group Type EXPERIMENTAL

TTV DNAemia

Intervention Type BIOLOGICAL

Every 3 months, one sample added at the same time (7mL) of a routine laboratory analysis for TTV DNAemia

EQ-5D-5L questionnaire

Intervention Type OTHER

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

Biological tests

Intervention Type BIOLOGICAL

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

Standard Immunosuppression

TTV DNAemia will also be measured every 3 months but the results will not be communicated to the physicians. Instead, the adaptation of the dose of maintenance immunosuppressive drugs will be performed according to the current standard of care: i) the dose of the CNI will be adapted to maintain the trough levels, monitored in the circulation every 3 month, between 5-10 ng/mL for tacrolimus (75-150 ng/mL for cyclosporin) and ii) the dose of MMF will be adjusted to maintain the AUC, measured every year, between 30-60 h.mg/L.

Group Type OTHER

TTV DNAemia

Intervention Type BIOLOGICAL

Every 3 months, one sample added at the same time (7mL) of a routine laboratory analysis for TTV DNAemia

EQ-5D-5L questionnaire

Intervention Type OTHER

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

Biological tests

Intervention Type BIOLOGICAL

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

Interventions

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TTV DNAemia

Every 3 months, one sample added at the same time (7mL) of a routine laboratory analysis for TTV DNAemia

Intervention Type BIOLOGICAL

EQ-5D-5L questionnaire

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

Intervention Type OTHER

Biological tests

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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 or vaccination within 3 months before 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No