TTV-based MAnagement of Long-term ImmunosuppreSsion in Kidney Transplantation

Launched by HOSPICES CIVILS DE LYON · Feb 11, 2025

Keywords

ClinConnect Summary

The TTV-based Management of Long-term Immunosuppression in Kidney Transplantation trial, also known as the TAOIST study, is exploring how to better manage medications for kidney transplant patients after their first year. Researchers want to see if monitoring a harmless virus called Torque Teno Virus (TTV) every three months can help personalize immunosuppressive therapy. This means they hope to adjust the medications patients take to prevent complications like infections, rejection of the kidney, and cancer, ensuring better long-term health and graft survival.

To participate in this study, you need to be an adult (18 years or older) who has received a kidney transplant within the last 1 to 4 years, with stable kidney function and specific treatment requirements. You also need to have a detectable level of TTV in your blood but no signs of certain complications like active rejection or uncontrolled infections. Participants in the trial can expect regular monitoring and personalized care based on their TTV levels, which may help improve their overall health and reduce the risk of serious complications. This study is still in the planning stage and has not yet started recruiting participants.

Gender

ALL

Eligibility 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