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

Summary 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.