Tocilizumab in Lung Transplantation (NCT06033196) | Clinical Trial Compass
RecruitingPhase 2
Tocilizumab in Lung Transplantation
United States350 participantsStarted 2024-02-13
Plain-language 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
Who can participate
Age range
12 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Serum Immunoglobulin G (IgG) level greater than 400 mg/dL. Patients treated with intravenous immune globulin (IVIG) for hypogammaglobulinemia are eligible for enrollment if their serum IgG level is greater than 400 mg/dL 14 or more days after the most recent IVIG treatment
. For women of child-bearing potential, willingness to use highly-effective contraception; according to the Food and Drug Administration (FDA) Office of Women's Health (http://www.fda.gov/birthcontrol).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects who meet any one of the pre-specified events detailed in the outcome description: from Baseline up to 36 months
Timeframe: Over a period of 3 years after randomization
Trial details
NCT IDNCT06033196
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Tested negative for latent TB infection (LTBI) using a PPD or interferon-gamma release assay (i.e., QuantiFERON-TB, T-SPOT.TB) within 1 year prior to transplant or has completed appropriate LTBI therapy within the 1 year prior to transplant
. Vaccinations must be up to date per the Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials
Exclusion criteria
. 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
. History of severe allergic and/or anaphylactic reactions to humanized or murine monoclonal antibodies
. Known hypersensitivity or previous treatment with ACTEMRA(R) (tocilizumab) within the last 3 months
. Infection with human immunodeficiency virus (HIV)
. Hepatitis B virus surface antigen or core antibody positive