Tocilizumab in Lung Transplantation

Summary

This is a trial in which 100 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) development of de novo donor specific antibodies (DSA), c) acute cellular rejection ≥A2, d) listed for re-transplantation, and e) death

Timeline

Start

2024-02-13

Primary completion

2029-01-08

Completion

2029-01-08

Drugs

Indications

No indication recorded.