Preliminary assessment of safety and adherence to a once‐daily immunosuppression regimen in kidney transplantation: Results of a randomized controlled pilot study

Medication non‐adherence is common after transplant and a major contributor to graft loss. The objective of this pilot study was to obtain preliminary safety and adherence data of a complete once‐daily immunosuppression regimen of Extended‐release‐tacrolimus (LCP‐tac), everolimus, and prednisone vs LCP‐tac, mycophenolate Twice daily (BID), and prednisone through a randomized controlled pilot study of 40 patients (20 in each arm). At 3 ± 2 months post‐transplant, patients were randomized to receive LCP‐tac and everolimus once daily or LCP‐tac and mycophenolate BID (control arm) for 6 months; 80 met eligibility, and 40 were randomized. Mean age was 51 ± 14 years, 33% were female, 45% African American, and 55% had a Calculated panel reactive antibody (cPRA) >20%. Both regimens were well‐tolerated, and medication side effect burden tended to be less severe in the intervention group. Self‐reported high medication adherence decreased in the control arm from baseline to 6 months (80%‐59%), while remaining the same in the intervention arm throughout the study (45%‐47%). For safety assessment, there was no rejection, graft loss, or death in either arm. These results provide preliminary evidence of the safety of a novel once‐daily immunosuppression regimen. The impact of this once‐daily regimen on medication adherence requires a larger long‐term study.