drugset / Trial / NCT06033196

Tocilizumab in Lung Transplantation

NCT06033196

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a trial in which 350 primary lung transplant recipients will be randomized (1:1) to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance immunosuppression or placebo (sterile normal saline) plus standard triple maintenance immunosuppression (Tacrolimus, Mycophenolate Mofetil, corticosteroids). The primary objective is to test the hypothesis that treatment with triple maintenance immunosuppression plus Tocilizumab (TCZ) is superior to triple maintenance immunosuppression plus placebo (saline) as defined by a composite endpoint of a) CLAD, b) listed for re-transplantation, and c) death

Timeline

Start
2024-02-13
Primary completion
2029-01-08
Completion
2029-01-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody

Indications

No indication recorded.