Tocilizumab in Lung Transplantation

PHASE2RecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

February 13, 2024

Primary Completion Date

January 8, 2029

Study Completion Date

January 8, 2029

Conditions
Lung Transplant
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"

Trial Locations (14)

10032

RECRUITING

Columbia University Medical Center (Site #: 71113), New York

21201

WITHDRAWN

University of Maryland Medical Center (Site #: 71138), Baltimore

27710

RECRUITING

Duke University Medical Center (Site #: 71139), Durham

44195

RECRUITING

Cleveland Clinic (Site #: 71101), Cleveland

63110

RECRUITING

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

WITHDRAWN

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

75390

RECRUITING

University of Texas Southwestern (Site #: 71187), Dallas

77030

WITHDRAWN

Houston Methodist Hospital (Site #: 71120), Houston

84132

RECRUITING

University of Utah Medical Center (Site #: 71126), Salt Lake City

85013

RECRUITING

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

90048

RECRUITING

Cedars Sinai Medical Center (Site #: 71146), Los Angeles

90095

RECRUITING

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

02114

RECRUITING

Massachusetts General Hospital (Site #: 71107), Boston

02215

WITHDRAWN

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

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH