Tocilizumab in Cardiac Transplantation (NCT03644667) | Clinical Trial Compass
CompletedPhase 2
Tocilizumab in Cardiac Transplantation
United States385 participantsStarted 2018-12-20
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
✓. Recipient of a primary heart transplant;
Exclusion criteria
✕. 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;
✕
What they're measuring
1
Proportion of Participants Positive for Event of dnDSA, ACR, AMR, Hemodynamic Compromise, Death or Re-Transplantation - By Treatment Group
Timeframe: From transplant through 12 months post transplant surgery (12 months)
Trial details
NCT IDNCT03644667
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)