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RECRUITING
NCT06033196
PHASE2

Tocilizumab in Lung Transplantation

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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

Official title: Targeting Inflammation and Alloimmunity in Lung Transplant Recipients With Tocilizumab (CTOT-45)

Key Details

Gender

All

Age Range

12 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2024-02-13

Completion Date

2029-01-08

Last Updated

2026-03-27

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tocilizumab

The initial dose of tocilizumab will be administered in the operating room before reperfusion of the first lung during the lung transplant surgery. 6 doses will be given once every four weeks over a 20-week period. The dose is approved for pediatric patients who weigh 30 kg or more

DRUG

Placebo for Tocilizumab

Placebo 0.9% Sodium Chloride Injection USP (Normal Saline) Placebo will be given as a single intravenous dose, volume matched to tocilizumab. Placebo will be administered over a period of approximately 60 minutes; once every four weeks over a 20-week period. The first placebo dose will be during the transplant surgery before reperfusion of the first lung allograft, with 5 subsequent monthly doses

Locations (21)

St. Joseph's Hospital and Medical Center (Site #: 71192)

Phoenix, Arizona, United States

Cedars Sinai Medical Center (Site #: 71146)

Beverly Hills, California, United States

David Geffen School of Medicine at UCLA (Site #: 71123)

Los Angeles, California, United States

University of Florida Shands Hospital (Site #: 71131)

Gainesville, Florida, United States

Emory University (Site #: 71103)

Atlanta, Georgia, United States

University of Maryland Medical Center (Site #: 71138)

Baltimore, Maryland, United States

Massachusetts General Hospital (Site #: 71107)

Boston, Massachusetts, United States

Boston Children's Hospital and Harvard Medical School (Site #: 71001)

Boston, Massachusetts, United States

Mayo Clinic Rochester (Site #: 71160)

Rochester, Minnesota, United States

Barnes Jewish Hospital/ Washington University SOM (Site #: 71191)

St Louis, Missouri, United States

St. Louis Children's Hospital of Washington University (Site #: 71006)

St Louis, Missouri, United States

Columbia University Medical Center (Site #: 71113)

New York, New York, United States

Duke University Medical Center (Site #: 71139)

Durham, North Carolina, United States

Cleveland Clinic (Site #: 71101)

Cleveland, Ohio, United States

Ohio State University Medical Center (Site #: 71196)

Columbus, Ohio, United States

Temple University (Site #: 71197)

Philadelphia, Pennsylvania, United States

Vanderbilt University (Site #: 71174)

Nashville, Tennessee, United States

University of Texas Southwestern (Site #: 71187)

Dallas, Texas, United States

Houston Methodist Hospital (Site #: 71120)

Houston, Texas, United States

University of Texas Health Science at San Antonio (Site #: 71198)

San Antonio, Texas, United States

University of Utah Medical Center (Site #: 71126)

Salt Lake City, Utah, United States