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 range12 Years – 75 Years

SexALL

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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).
✓. 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

What they're measuring

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)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2029-01-08

Contact for this trial

Yvonne Morrison, MS

301-706-9137 ymorrison@niaid.nih.gov

View on ClinicalTrials.gov More Lung Transplant trials