RecruitingNot ApplicableNCT06829719

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

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


Sponsor

Hospices Civils de Lyon

Enrollment

300 participants

Start Date

Apr 23, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a virus called TTV (torque teno virus) — which is harmless but reflects how well your immune system is working — can help doctors personalize and reduce the amount of immune-suppressing medication given to kidney transplant recipients, potentially reducing side effects while protecting the transplanted kidney. **You may be eligible if...** - You are 18 years or older - You have received a kidney transplant (first, second, or third transplant) - Your transplant was 12 to 48 months ago - Your kidney is functioning stably (minimal changes in creatinine over the past 6 months, low protein in urine) - You are currently on a maintenance immunosuppression regimen that includes tacrolimus or cyclosporine plus mycophenolate - TTV is detectable in your blood - You have no detectable donor-specific antibodies or BK virus in your blood **You may NOT be eligible if...** - You have received an HLA-identical kidney - Your kidney function is unstable or declining - You have donor-specific antibodies or active BK virus infection - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTTV DNAemia

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

OTHEREQ-5D-5L questionnaire

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

BIOLOGICALBiological tests

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


Locations(4)

Service de Néphrologie-Transplantation-Dialyse I Hôpital Pellegrin I - CHU Bordeaux

Bordeaux (France), France

Service de transplantation, néphrologie et immunologie clinique Hospices Civils de Lyon, Hôpital Edouard Herriot

Lyon, France

Service de Néphrologie, Dialyse et Transplantation Rénale Nouvel Hôpital Civil

Strasbourg (france), France

Département de Néphrologie et Transplantation d'Organes Hôpital Rangueil - CHU de Toulouse

Toulouse (France), France

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NCT06829719


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