Tocilizumab in Lung Transplantation
ConditionLung Transplant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-75
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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
Eligibility criteria
Qualifiers
Subject and/or parent guardian must be able to understand the purpose of the study and willing to participate and sign informed consent/assent
Greater than or equal to 30 kg body weight
Listed or received for a primary lung transplant
No previous or planned desensitization therapy prior to transplant
Disqualifiers
Listed for multi-organ transplant (e.g., heart-lung, liver-lung, kidney-lung)
Prior history of allogeneic organ or cellular transplantation
Received treatment to deplete Human Leukocyte Antigens (HLA) antibodies before transplantation
Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period
Trial design
Treatments tested in this trial
- Tocilizumab
- Placebo for Tocilizumab
Treatment groups
350 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov