Tacrolimus Metabolism and Renal Function Following Renal Transplantation Using Once-Daily Envarsus XR as Compared to Twice-Daily Prograf
Name: Averill Clapp
School: Vagelos College of Physicians and Surgeons, Class of 2023
Mentor: Mark A. Hardy, MD and Annette Wu, MD, MPH, PhD
Abstract
Tacrolimus is the most commonly used maintenance immunosuppressive calcineurin inhibitor (CNI) in renal transplantation. Tacrolimus metabolism is known to vary widely across transplant recipients, especially among African Americans, and excess exposure to the drug may contribute significantly to CNI nephrotoxicity over the long term. In this prospective randomized preliminary study, we sought to investigate the impact of tacrolimus metabolism rate on nephrotoxicity as determined by serum creatinine levels obtained serially over a one-year period following renal transplantation. The study was conducted in 50 patients, 45 of whom completed one year of observation. Participants received either a twice-daily immediate release tacrolimus formulation (Prograf) or a once-daily extended release tacrolimus formulation (Envarsus XR). We hypothesized that patients treated with Envarsus XR may achieve more consistent calcineurin exposure with overall lower doses of tacrolimus, decreasing the risk of CNI nephrotoxicity. We also analyzed differences in tacrolimus metabolism and renal function outcomes among African American (AA) patients and patients of other races. We did not find significant differences within the Prograf and Envarsus XR groups with regards to tacrolimus metabolism, blood trough concentrations, or total tacrolimus dose per patient. We did, however, observe that AA recipients demonstrated faster tacrolimus metabolism on average and higher mean serum creatinine levels than their counterparts. While a future study with increased statistical power will be needed to validate our preliminary findings, the trends observed in this study may be useful in predicting who may be at higher risk of CNI nephrotoxicity and help to avoid it.
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