TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation (NCT06829719) | Clinical Trial Compass
RecruitingNot Applicable
TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation
France600 participantsStarted 2025-04-23
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: through study completion, an average of 6 years