LCPT once‐daily extended‐release tacrolimus tablets versus twice‐daily capsules: a pooled analysis of two phase 3 trials in important de novo and stable kidney transplant recipient subgroups

African‐American and elderly kidney transplant recipients (KTR) have increased risk for poor clinical outcomes post‐transplant. Management of immunosuppression may be challenging in these patients and contribute to worse outcomes. A novel once‐daily formulation of tacrolimus (LCPT) has demonstrated noninferiority, similar safety, improved bioavailability, a consistent concentration time profile, and less peak and peak‐trough fluctuations vs. tacrolimus twice‐daily (Tac BID). This pooled analysis of two phase 3 randomized, controlled trials, including 861 (LCPT N = 428; Tac BID N = 433; 38% of patients were stable KTR, and 62% were de novo KTR) patients, examined the efficacy of LCPT in KTR subgroups (blacks, females, and age ≥65). Overall, treatment failure [death, graft failure, centrally read biopsy‐proven acute rejection (BPAR), or lost to follow‐up] at 12 months was as follows: LCPT: 11.9%, BID Tac: 13.4% [?1.48% (?5.95%, 2.99%)]. BPAR rates were as follows: LCPT: 8.2%, Tac BID: 9.5% [?1.29% (?5.14%, 2.55%)]. Numerically, fewer treatment failure events with LCPT were found in the majority of subgroups, with significantly less treatment failure associated with LCPT among black KTR [?13.82% (?27.22%, ?0.31%)] and KTR ≥65 [?13.46% (?25.27%, ?0.78%)]. This pooled analysis suggests numerically lower efficacy failure rates associated with LCPT among high‐risk subgroups, in particular black KTR and KTR ≥65 years old.