A Comparative Study of Once-Daily versus Twice-Daily Tacrolimus in Deceased Donor Kidney Transplant Recipients: A National Cohort Analysis.

The comparative real-world effectiveness of extended-release (Life-Cycle Pharma Tacrolimus [LCPT]) versus immediate-release (IR) tacrolimus formulations in deceased-donor kidney transplantation remains incompletely characterized. We conducted a national retrospective cohort study of adult deceased-donor kidney transplant (DDKT) recipients in the OPTN/UNOS registry (1/1/2018-6/30/2023) discharged on tacrolimus plus mycophenolate. Multi-organ and living-donor transplants, and recipients who switched formulations during the index hospitalization, were excluded. Exposure was the tacrolimus formulation at discharge (IR-brand, IR-generic, or LCPT). The prespecified primary outcome was all-cause graft failure (ACGF), evaluated using inverse probability of treatment weighting (IPTW)-adjusted Cox models. Among 79,833 recipients, LCPT (n=11,581) was associated with a lower adjusted hazard of ACGF than IR-brand tacrolimus (0.877; 95% CI 0.797-0.965), whereas IR-generic and IR-brand did not differ (HR 0.939; 95% CI 0.868-1.016). The association was consistent in a sensitivity analysis restricted to centers prescribing all three formulations (HR 0.872; 95% CI 0.789-0.963) and in a propensity-score-matched analysis comparing LCPT with combined IR tacrolimus (HR 0.913; 95% CI 0.836-0.998). In this national DDKT cohort, LCPT was associated with a modestly lower adjusted risk of ACGF relative to IR tacrolimus.