Actively Recruiting
Tocilizumab in Lung Transplantation
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-03-27
350
Participants Needed
21
Research Sites
255 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Tocilizumab in Lung Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject and/or parent guardian must understand the study purpose and consent to participate
- Body weight at least 30 kg
- Listed for or received a primary lung transplant
- No previous or planned desensitization therapy before transplant
- Serum Immunoglobulin G (IgG) level above 400 mg/dL
- Women of child-bearing potential must agree to use highly effective contraception during the study and for 1 year after the last dose if using oral contraception
- Negative test for latent TB infection within 1 year before transplant or completed therapy
- Vaccinations up to date according to transplant trial guidance
- Provide informed consent to continue participation at randomization
- Received single or bilateral lung transplant
- Negative physical crossmatch at transplant or no special treatment needed
- Satisfactory bronchial healing seen on bronchoscopy
- Negative pregnancy test within 48 hours prior to randomization for women of child-bearing potential
- Recipients of lungs supported with ex vivo lung perfusion devices are allowed
You will not qualify if you...
- Listed for multi-organ transplant
- Previous allogeneic organ or cellular transplant
- Treated to deplete HLA antibodies before transplant
- Currently breastfeeding or planning pregnancy during study follow-up
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- Known allergy or treatment with Tocilizumab within last 3 months
- HIV infection
- Positive for hepatitis B surface antigen or core antibody
- Hepatitis C positive without sustained viral remission
- Chronic infection with Burkholderia cenocepacia or Burkholderia gladioli
- Non-tuberculous mycobacterial lung disease without culture conversion
- Active malignancy or cancer history under 5 years except certain treated skin or cervical cancers
- History of hemolytic-uremic syndrome or thrombotic thrombocytopenia purpura
- History of demyelinating disorders
- Current treatment with alkylating agents like cyclophosphamide
- History of gastrointestinal tract perforation
- History of inflammatory bowel disease except fully excised ulcerative colitis
- History of diverticulitis or diverticular bleeding
- Low platelet count (<100,000/mm^3) within 7 days before enrollment
- Low neutrophil count (<2,000/mm^3) within 7 days before enrollment
- Elevated liver enzymes (AST or ALT >3 times upper limit) within 7 days before enrollment
- Use of illegal drugs
- Smoking or vaping within 6 months before transplant listing
- Use of investigational drugs within 4 weeks before enrollment
- Any condition judged by the investigator to pose undue risk
- Multi-organ or tissue transplant recipient at randomization
- Clinically unstable with untreated infection
- Live virus vaccine within 30 days before randomization
- Treatment to deplete HLA antibodies to improve transplant chance
- Known donor-specific antibodies needing intervention
- History of GI perforation or inflammatory bowel disease
- History of diverticulitis or bleeding
- Severe allergic reactions to monoclonal antibodies
- Hypersensitivity to Tocilizumab
- Previous Tocilizumab treatment within 3 months
- HIV infection in recipient or donor
- Hepatitis B positive recipient or donor without protective antibody levels
- Hepatitis C positive donor organ recipient
- Latent TB infection without completed treatment
- Chronic Burkholderia infection
- Non-tuberculous mycobacterial lung disease without clearance
- Active cancer except certain skin cancers
- History of hemolytic-uremic syndrome or thrombotic thrombocytopenia purpura
- History of demyelinating disorders
- Ongoing treatment with alkylating agents
- Elevated liver enzymes (AST or ALT >1.5 times upper limit) within 1 day before randomization
- Low platelets or neutrophils within 1 day before randomization
- Use of anti-thymocyte globulin as induction therapy immediately after transplant
- Treatment with immunomodulatory biological agents within past 3 months or anticipated
- Use of investigational drugs after transplant
- Smoking or vaping since enrollment
- Any condition posing undue risk per investigator opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
St. Joseph's Hospital and Medical Center (Site #: 71192)
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Cedars Sinai Medical Center (Site #: 71146)
Beverly Hills, California, United States, 90211
Actively Recruiting
3
David Geffen School of Medicine at UCLA (Site #: 71123)
Los Angeles, California, United States, 90095
Actively Recruiting
4
University of Florida Shands Hospital (Site #: 71131)
Gainesville, Florida, United States, 32610
Not Yet Recruiting
5
Emory University (Site #: 71103)
Atlanta, Georgia, United States, 55905
Not Yet Recruiting
6
University of Maryland Medical Center (Site #: 71138)
Baltimore, Maryland, United States, 21201
Withdrawn
7
Massachusetts General Hospital (Site #: 71107)
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Boston Children's Hospital and Harvard Medical School (Site #: 71001)
Boston, Massachusetts, United States, 02215
Withdrawn
9
Mayo Clinic Rochester (Site #: 71160)
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
10
Barnes Jewish Hospital/ Washington University SOM (Site #: 71191)
St Louis, Missouri, United States, 63110
Actively Recruiting
11
St. Louis Children's Hospital of Washington University (Site #: 71006)
St Louis, Missouri, United States, 63110
Withdrawn
12
Columbia University Medical Center (Site #: 71113)
New York, New York, United States, 10032
Actively Recruiting
13
Duke University Medical Center (Site #: 71139)
Durham, North Carolina, United States, 27710
Actively Recruiting
14
Cleveland Clinic (Site #: 71101)
Cleveland, Ohio, United States, 44195
Actively Recruiting
15
Ohio State University Medical Center (Site #: 71196)
Columbus, Ohio, United States, 43210
Not Yet Recruiting
16
Temple University (Site #: 71197)
Philadelphia, Pennsylvania, United States, 19140
Not Yet Recruiting
17
Vanderbilt University (Site #: 71174)
Nashville, Tennessee, United States, 37232-0393
Not Yet Recruiting
18
University of Texas Southwestern (Site #: 71187)
Dallas, Texas, United States, 75390
Actively Recruiting
19
Houston Methodist Hospital (Site #: 71120)
Houston, Texas, United States, 77030
Withdrawn
20
University of Texas Health Science at San Antonio (Site #: 71198)
San Antonio, Texas, United States, 78229
Not Yet Recruiting
21
University of Utah Medical Center (Site #: 71126)
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
Y
Yvonne Morrison, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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