TTV-guided long-term immunosuppression in kidney transplant recipients
Personalization of Maintenance Immunosuppression Based on TTV Viral Load to Prevent Long-term Complications in Renal Transplantation
NA · Hospices Civils de Lyon · NCT06829719
This trial tests whether checking Torque Teno Virus (TTV) levels every three months starting in the second year after transplant can help tailor immunosuppressive drugs for adult kidney transplant recipients to reduce infections, rejection, and cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 4 sites (Bordeaux (France) and 3 other locations) |
| Trial ID | NCT06829719 on ClinicalTrials.gov |
What this trial studies
TAOIST is a multicenter interventional trial that uses serial Torque Teno Virus (TTV) DNAemia measurements every three months beginning 12 months after kidney transplantation to guide maintenance immunosuppression. Adult recipients 12–48 months post-transplant with stable graft function, detectable TTV, no donor-specific antibodies, and standard CNI plus MMF regimens are enrolled and monitored with TTV testing, routine biological assays, and EQ-5D-5L quality-of-life questionnaires. The protocol personalizes immunosuppressant dosing based on TTV kinetics and adherence signals to balance risks of infection and cancer against rejection. Outcomes include rates of rejection, infections, malignancy, graft function changes, and patient-reported quality of life over follow-up.
Who should consider this trial
Good fit: Ideal candidates are adults 12–48 months after a kidney transplant with stable graft function, on a calcineurin inhibitor plus mycophenolate maintenance regimen, detectable TTV DNAemia, no circulating donor-specific antibodies, and willing to attend regular follow-up visits.
Not a fit: Patients unlikely to benefit include those with HLA-identical or multiple-organ transplants, those on mTOR inhibitors or belatacept, patients with recent or active rejection or uncontrolled infection, or those with undetectable TTV DNAemia.
Why it matters
Potential benefit: If successful, this approach could allow clinicians to safely tailor or reduce immunosuppression for individuals, lowering infection and cancer risk while preserving graft health.
How similar studies have performed: Observational studies have shown correlations between TTV load and immunosuppression depth and infection risk, but routine TTV-guided long-term dosing is a relatively novel approach without broad proof from randomized trials yet.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux (France) and 3 other locations
- Service de Néphrologie-Transplantation-Dialyse I Hôpital Pellegrin I - CHU Bordeaux — Bordeaux (France), France (NOT_YET_RECRUITING)
- Service de transplantation, néphrologie et immunologie clinique Hospices Civils de Lyon, Hôpital Edouard Herriot — Lyon, France (RECRUITING)
- Service de Néphrologie, Dialyse et Transplantation Rénale Nouvel Hôpital Civil — Strasbourg (france), France (NOT_YET_RECRUITING)
- Département de Néphrologie et Transplantation d'Organes Hôpital Rangueil - CHU de Toulouse — Toulouse (France), France (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Olivier THAUNAT, Professor MD, PhD
- Email: olivier.thaunat@chu-lyon.fr
- Phone: +334.72.11.69.28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infection, Cancer, Rejection, Kidney Transplantation, TTV, Biomarker, immunosuppression, precision medicine