*Purpose: This study is being conducted to evaluate the clinical impact of the utilization of tacrolimus LCP (TAC-LCP) compared to tacrolimus immediate release (TAC-IR) in African Americans as a part of de novo maintenance immunosuppression.

*Methods: Single-center, retrospective chart review comparing the outcomes of African American kidney transplant recipients who received TAC-LCP to those who received TAC-IR between March 1, 2013 and March 1, 2018. Per institutional protocol, African American kidney transplant recipients are initiated on TAC-LCP no later than post-operative day two dosed at 4mg daily. The primary efficacy endpoint of this study was treated acute rejection within the first 12 months after transplant. Time to therapeutic tacrolimus trough, incidence of cytomegalovirus (CMV) and BK infection, and eGFR 6 and 12 months post-transplant served as additional study outcomes.

*Results: A total of 300 patients were screened for inclusion with 86 patients meeting inclusion criteria: 23 in the TAC-LCP arm and 63 in the TAC-IR arm. The majority of patients were excluded due to being of non-African American ethnicity. Average age of patients in both arms was 53 years, and the majority were male (65% TAC-LCP vs 62% TAC-IR; P= 0.778). The majority of patients received cadaveric renal transplants in both arms (78% vs 90.5%; P=0.778). No statistical difference was found between groups in CMV serostatus. No statistically significant difference was found in treated acute rejection between the TAC-LCP and TAC-IR arms (14.3% vs9.5%; P=0.684). Median time to therapeutic tacrolimus trough was 17 (IR 13-22) and 14 days (IR 9.3-21.8; P=0.333). No significant difference in patient survival was observed between study arms (TAC-LCP 100% vs TAC-IR 98.5%). A trend towards lower rates of CMV (4.7% vs 15.8%; P=0.227) and BK (14.2% vs 30%; P=0.251) infections was observed in the TAC-LCP compared to the TAC-IR arm. No significant difference was found in median eGFR between arms at 6 months (61 (IR 49-81) vs 61.65 (IR 45-77.5) ml/min/1.73m²; P=0.320) or 12 months post-transplant (63.15 (51.43-76.93) vs 67.6 (IR 46-78.9) ml/min/1.73m²; P=0.771).

*Conclusions: The use of TAC-LCP in the African American kidney transplant patients as part of de novo maintenance immunosuppression resulted in similar acute rejection rates and time to therapeutic troughs compared to TAC-IR. The incidence of infectious complications and overall renal function were also similar between groups.

« Back to 2019 American Transplant Congress