Statistical analysis plan for TTVguideIT-a multicentre, patient- and assessor-blinded, non-inferiority, randomised and controlled phase II trial to compare standard and Torque Teno virus-guided immunosuppression in kidney transplant recipients in the first year after transplantation.

ABSTRACT:

Background

Non-interventional studies indicate an association between Torque Teno Virus (TTV) load in peripheral blood and immunosuppression related outcomes in kidney transplant recipients. This makes it a promising biomarker for guiding immunosuppression after kidney transplantation. The primary objective of the current trial is to demonstrate the safety, tolerability and preliminary efficacy of TTV-guided immunosuppression.

Methods

For this purpose, a randomised, controlled, interventional, two-arm, non-inferiority, patient- and assessor-blinded, international multicentre investigator-driven phase II trial was designed. A total of 260 stable, low-immunological-risk adult recipients of a kidney graft with Tacrolimus-based immunosuppression and TTV infection after month 3 p

SUBMITTER: Herkner F 

PROVIDER: S-EPMC12548177 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature