Tocilizumab in Cardiac Transplantation

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Transplant

In brief

The purpose of this research study is to see if a study drug called Tocilizumab will, when given with standard anti-rejection medicines, lead to better heart transplantation outcomes at 1 year after the transplant. Specifically, the investigators will evaluate whether taking tocilizumab leads to less rejection, less development of unwanted antibodies, and better heart function.

Key facts

Study ID: NCT03644667
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 385
Starts: 2018-12-20
Expected to finish: 2025-03-25
Last updated by the study team: 2026-04-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Inclusion Criteria- Study Entry
Subject must be able to understand and provide informed consent;
Is a candidate for a primary heart transplant (listed as a heart transplant only);
No desensitization therapy prior to transplant;
Agreement to use contraception: according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective.
Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from the above referenced list to be used for the duration of the study
Those who choose oral contraception must agree to use a second form of contraception after administration of study drug for a period of 1 year after the last dose of study drug.
Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted;
In the absence of contraindication, vaccinations should be up to date for hepatitis B, influenza, pneumococcal, zoster, and Measles, Mumps, \& Rubella (MMR); and
Subjects from areas of endemic coccidioidomycosis are eligible for inclusion but must be treated prophylactically with fluconazole or itraconazole.
Inclusion Criteria - Randomization
Recipient of a primary heart transplant;
Negative virtual crossmatch (according to local center criteria);
No desensitization therapy prior to transplant;
Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization; and
Agreement to use contraception: according to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective.
Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from the above referenced list to be used for the duration of the study
Those who choose oral contraception must agree to use a second form of contraception after administration of study drug for a period of 1 year after the last dose of study drug.
Negative SARS-CoV-2 real-time reverse transcription polymerase chain reaction (rRT-PCR) test result performed within 48 hours of transplant (SARS-CoV-2 is the virus that causes COVID-19)

You may not qualify if…

Exclusion Criteria Study Entry
Inability or unwillingness of a participant to give written informed consent or comply with study protocol;
Candidate for a multiple solid organ or tissue transplants;
Prior history of organ or cellular transplantation requiring ongoing systemic immunosuppression;
Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period;
History of severe allergic and/or anaphylactic reactions to humanized or murine monoclonal antibodies;
Known hypersensitivity to tocilizumab (Actemra®);
Previous treatment with tocilizumab (Actemra®);
Human Immunodeficiency Virus (HIV) positive;
Hepatitis B surface antigen positive;
Hepatitis B core antibody positive;
Hepatitis C virus antibody positive (anti-HCV Ab+) who are either untreated or, have failed to demonstrate sustained viral remission for more than 12 months (after anti-viral treatment);
Recipient of a Hepatitis C virus nucleic acid test (NAT) positive donor organ;
Subjects must be tested for latent TB infection (LTBI) within a year prior to transplant:
-Subjects with a positive test for LTBI must complete appropriate therapy for LTBI.
--A Subject is considered eligible only if they have a negative test for LTBI within one year prior to transplant OR
--- if they have completed appropriate LTBI therapy within one year prior to transplant.
Subjects with a previous history of active Tuberculosis (TB);
Subjects with a history of splenectomy;
Known active current viral, fungal, mycobacterial or other infections not including (left ventricular assist device [LVAD]) driveline infections;
History of malignancy less than 5 years in remission.
-Any history of adequately treated in-situ cervical carcinoma, low grade prostate carcinoma, or adequately treated basal or squamous cell carcinoma of the skin will be permitted.
History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura;
History of demyelinating disorders such as:
multiple sclerosis,

Where it is running

Cedars Sinai Medical Center (CACS) — Beverly Hills, California, United States
University of California, San Diego: Sulpizio Cardiovascular Center (CASD) — La Jolla, California, United States
Stanford Health Care (CASU) — Stanford, California, United States
Tampa General Hospital (FLTG) — Tampa, Florida, United States
Northwestern Memorial Hospital (INLM) — Chicago, Illinois, United States
Tufts Medical Center (MANM) — Boston, Massachusetts, United States
Massachusetts General Hospital (MAMG) — Boston, Massachusetts, United States
St. Luke's Hospital of Kansas City (MOLH) — Kansas City, Missouri, United States
University of Nebraska Medical Center (NEUN) — Omaha, Nebraska, United States
Mount Sinai Medical Center (NYMS) — New York, New York, United States
Columbia University Medical Center (NYCP) — New York, New York, United States
Montefiore Medical Center (NYMA) — The Bronx, New York, United States
Duke University Medical Center (NCDU) — Durham, North Carolina, United States
Cleveland Clinic Foundation (OHCC) — Cleveland, Ohio, United States
Penn State Health: Milton S. Hershey Medical Center (PAHE) — Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania (PAUP) — Philadelphia, Pennsylvania, United States
Allegheny General Hospital (PAAG) — Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center (TNVU) — Nashville, Tennessee, United States
Baylor University Medical Center (TXTX) — Dallas, Texas, United States
University of Utah (UTMC) — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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