TTV-guided long-term immunosuppression in kidney transplant recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Service de transplantation, néphrologie et immunologie clinique Hospices Civils de Lyon, Hôpital Edouard Herriot
  Lyon, France Recruiting
• Département de Néphrologie et Transplantation d'Organes Hôpital Rangueil - CHU de Toulouse
  Toulouse (France), France Recruiting
• Service de Néphrologie-Transplantation-Dialyse I Hôpital Pellegrin I - CHU Bordeaux
  Bordeaux (France), France Not yet recruiting
• Service de Néphrologie, Dialyse et Transplantation Rénale Nouvel Hôpital Civil
  Strasbourg (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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.