Viral load-guided immunosuppression after lung transplantation (VIGILung)—study protocol for a randomized controlled trial

Abstract Background Immunosuppression including high-dose calcineurin inhibitors (CNI) is essential after lung transplantation. Dosing usually guided by therapeutic drug monitoring adjusted to target trough levels of CNIs keep the balance between over-dose causing severe toxicity and increased risk infections or under-dose with a graft injury. Adaptation CNI-based immunosuppression torque teno virus (TTV), latent nonpathogenic DNA virus, measured in whole blood addition conventional may reduce similar efficacy. Methods/design An open-label, randomized, controlled, parallel-group, multicenter trial transplant recipients will be conducted investigate safety efficacy TTV as an add-on monitoring. Adult 21 42 days transplantation are eligible participate. Patients ( N = 144) randomized 1:1 experimental intervention (arm 1: tacrolimus levels) control 2: monitoring). Outcomes assessed 12 months randomization change glomerular filtration rate primary endpoint. Secondary endpoints additional measurements renal function, allograft incidence acute rejections, chronic dysfunction, loss, infections. Discussion The results this controlled while maintaining immunosuppression. Study transferable all other solid organ transplantations. Trial registration ClinicalTrials.gov NCT04198506 . Registered on December 2019