April 14, 2018
Mayo Clinic is conducting a clinical trial of a genomic strategy for preventing organ rejection after kidney transplantation. The observational study uses periodic genomic testing of patients' blood in an effort to fine-tune post-transplant immunosuppressant drug regimens.
"Genomic analysis of blood can reveal early signs of rejection in transplanted kidneys," says Mark D. Stegall, M.D., a transplant surgeon at Mayo Clinic in Rochester, Minnesota, and the study's principal investigator. "The potential clinical utility is to be able to monitor for rejection more frequently than is possible with surveillance biopsies and to individualize immunosuppression in transplant recipients."
Mayo Clinic's Center for Individualized Medicine and the transplant programs at Mayo's campuses in Arizona, Florida and Minnesota are conducting the study in collaboration with Transplant Genomics, a molecular diagnostics company. The trial, known as Transplant Organ Genomics to Help Prevent Rejection in Heart Transplant Recipients, or TOGETHER, utilizes a peripheral blood RNA signature that has been shown to correlate with rejection in kidney transplants. Patients at all three Mayo Clinic campuses are being enrolled in the trial.
The 250 kidney transplant recipients enrolled in the trial will be managed using standard of care clinical protocols at the three Mayo Clinic transplant sites. Study participants will have genomic testing at five intervals throughout their first postoperative year. The data may help transplant care teams adjust immunosuppression drug regimens and improve patient outcomes.
"The promise of individualized medicine is that we can now use information found in a patient's own genetic code to provide more personalized answers about the patient's medical care. TOGETHER will make that promise more of a reality for our transplant patients," says Alexander S. Parker, Ph.D., the Cecilia and Dan Carmichael Family Associate Director for the Center for Individualized Medicine at Mayo Clinic in Jacksonville, Florida.
The clinical trial is part of a multiyear collaboration between Mayo and Transplant Genomics, which also includes an assessment of the company's TruGraf test for renal transplant monitoring and the development of new tests and technologies for additional targets, including exploratory studies in heart and liver transplantation.
For more information
Clinical trial: The TOGETHER Project — Transplant Organ Genomics to Help Prevent Rejection in Heart Transplant Recipients. Mayo Clinic.