Tocilizumab in Lung Transplantation
This study is looking at whether adding Tocilizumab to standard medications can improve outcomes for people receiving a lung transplant. Researchers will compare Tocilizumab plus standard care to a placebo (a saline solution) plus standard care. You might be able to join if you are between 12 and 75 years old, weigh at least 30 kg, and are getting your first lung transplant. The study will enroll 350 participants. The main goal is to see if Tocilizumab can help prevent problems like chronic lung allograft dysfunction (CLAD), needing another transplant, or death within three years after your transplant. The current status of this study is unclear.
- Study design
- This is an interventional study where 350 participants will be randomly assigned to receive either Tocilizumab or a placebo, in addition to standard medications. The phase of the study is not specified.
- What's involved
- If you participate, you would receive six doses of either Tocilizumab or placebo once every four weeks over a 20-week period. The first dose is given during your lung transplant surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 36 months (3 years) after they are randomly assigned to a treatment group.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Tocilizumab in Lung Transplantation
At a glance
Conditions
Where it's being run
21 sites across 15 statesStudy leadership
- Joren Madsen, MD, D.Phil. · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
- Ramsey Hachem, MD · STUDY_CHAIR · University of Utah Medical Center
- Daniel Kreisel, M.D. · STUDY_CHAIR · Washington University School of Medicine
Who to contact
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What this trial measures
- Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline up to 36 monthsOver a period of 3 years after randomization
1. The development of Chronic Lung Allograft Dysfunction (CLAD) * The development of any form of CLAD will be defined according to the standard 2019 The International Society for Heart and Lung Transplantation (ISHLT) criteria. 2. Listed for re-transplantation * Re-transplantation defined as the subject has been formally registered on the United Network for Organ Sharing (UNOS) waiting list to undergo a second lung transplant surgery 3. Death * Primary analysis will be conducted according to an Intent-to-treat (ITT) principle and therefore will include all randomized subjects who receive Tocilizumab(TCZ) or placebo. The time from randomization to development of CLAD will be compared between the two treatment groups (TCZ vs. placebo) using a Pearson's chi-square test.