Clinical Trials Directory

People in this study will receive medicines to help prevent infections after a kidney transplant. They will be placed into one of two groups by chance. One group will receive a study medicine called frexalimab, while the other group will receive tacrolimus, a standard anti rejection medicine. Frexalimab is given right after the transplant, then again two weeks later, four weeks later, and every four weeks after that for up to five years. Participants will have regular blood tests, urine tests, physical exams, heart tests, questionnaires, and kidney biopsies to monitor their health and the transplanted kidney. Some activities, such as interviews and physical activity tracking, are optional. Researchers want to learn if frexalimab is a safe and effective alternative to tacrolimus for preventing kidney transplant rejection.

If you join the study, you will sign a consent form, complete a questionnaire, and provide a blood sample. You will also have your regular low-dose CT scan for lung cancer screening as part of your usual medical care. The study team will review your medical records and follow your health for about 2 years.

We are doing this study to understand more about biomarkers (a part of your body) and how they can be used to better diagnose infection. To learn more, please contact us at DukeMESSIStudy@Duke.edu or at 919-452-1605. Estamos haciendo este estudio para entender más sobre biomarcadores (que son parte de su cuerpo) y cómo pueden ser usados estos para diagnosticar infecciones de una mejor manera. Para mayor información, por favor contáctenos al correo DukeMESSIStudy@Duke.edu o al número 919-452-1605.

We are doing this study to learn more about the cause of cardiac (heart) disease or sudden unexplained death, which is something that can run in families. Some conditions that we are looking at are:

• Cardiomyopathies (a disease of the heart muscle that makes it harder for your heart to pump blood to the rest of your body) like hypertrophic cardiomyopathy, dilated cardiomyopathy, or arrhythmogenic cardiomyopathy (also called right ventricular cardiomyopathy)
• Arrhythmia syndromes (a problem with the rate or rhythm of the heartbeat, either too slow or too fast) like long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia, or short QT syndrome
• Sudden cardiac arrest or unexplained sudden death (heart stops suddenly) in someone less than 50 years of age, including sudden infant death syndrome (SIDS)
• Individuals with genetic mutations (variants) in genes that can lead to cardiac disease which include (LMNA, ATP1A3, and TAX1BP3)

We are doing this study to learn more about how genetic variations in people can impact how well different antibody-based drugs work for people who get organ transplants.

This is an observational study and will only be a one-time saliva sample and a completion of a questionnaire.