Tocilizumab in Lung Transplantation (NCT06033196)
Targeting Inflammation and Alloimmunity in Lung Transplant Recipients With Tocilizumab (CTOT-45)
๐ฉบ Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: St. Joseph's Hospital and Medical Center (Site #: 71192) โ Phoenix, Arizona
Age range: 12 Years to 75 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (21 Sites)
- St. Joseph's Hospital and Medical Center (Site #: 71192) โ Phoenix, Arizona
- Cedars Sinai Medical Center (Site #: 71146) โ Beverly Hills, California
- David Geffen School of Medicine at UCLA (Site #: 71123) โ Los Angeles, California
- University of Florida Shands Hospital (Site #: 71131) โ Gainesville, Florida
- Emory University (Site #: 71103) โ Atlanta, Georgia
- University of Maryland Medical Center (Site #: 71138) โ Baltimore, Maryland
- Massachusetts General Hospital (Site #: 71107) โ Boston, Massachusetts
- Boston Children's Hospital and Harvard Medical School (Site #: 71001) โ Boston, Massachusetts
- Mayo Clinic Rochester (Site #: 71160) โ Rochester, Minnesota
- Barnes Jewish Hospital/ Washington University SOM (Site #: 71191) โ St Louis, Missouri
- St. Louis Children's Hospital of Washington University (Site #: 71006) โ St Louis, Missouri
- Columbia University Medical Center (Site #: 71113) โ New York, New York
- Duke University Medical Center (Site #: 71139) โ Durham, North Carolina
- Cleveland Clinic (Site #: 71101) โ Cleveland, Ohio
- Ohio State University Medical Center (Site #: 71196) โ Columbus, Ohio
- Temple University (Site #: 71197) โ Philadelphia, Pennsylvania
- Vanderbilt University (Site #: 71174) โ Nashville, Tennessee
- University of Texas Southwestern (Site #: 71187) โ Dallas, Texas
- Houston Methodist Hospital (Site #: 71120) โ Houston, Texas
- University of Texas Health Science at San Antonio (Site #: 71198) โ San Antonio, Texas
- University of Utah Medical Center (Site #: 71126) โ Salt Lake City, Utah
๐ Contact the Study Coordinator
Phone: (301) 706-9137
Email: ymorrison@niaid.nih.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Lung Transplant
- An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant โ Cleveland, Ohio
- 10ยฐC vs 4ยฐC Lung Preservation RCT โ Phoenix, Arizona
- Targeting Interferon Gamma With Emapalumab to Lung Transplant Recipients With Interferon Gamma-high Acute Lung Allograft Dysfunction โ Los Angeles, California
- GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejection in Lung Transplantation โ Bethesda, Maryland
- A Study of Latin Dance for Post- Lung Transplant โ Jacksonville, Florida
- Bridge to Lung Transplant With Trans-septal Extra-corporeal Membrane Oxygenation (ECMO) for Right Heart Failure From Pulmonary Hypertension โ Jacksonville, Florida
Explore by condition: All Lung Transplant clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.