Comparing the Effectiveness of Different Tacrolimus-Containing Medications Used in Daily Patient Care for Adult Kidney Transplant Patients, in Transplant Centres of Eastern Hungary in a Prospective Non-Interventional Study (DeSz study)

Background and hypothesis: Because of the narrow therapeutic range and inter-individual differences in tacrolimus trough levels, the total daily dose and their ratio are commonly used to determine proper tacrolimus. In our study, the Life-Cycle Pharma-tacrolimus formulation was compared to Immediate-release Tacrolimus in a real-life setting. Methods: This longitudinal observational study included kidney transplant patients at two Hungarian university clinic’s study centers. Sixty-three (63) patients completed the study and were included in the statistical analysis. They received either Life-Cycle Pharma-tacrolimus (n=40) or Immediate-release Tacrolimus (n=23) maintenance therapy as the two study arms, all combined with everolimus or mycophenolic acid and corticosteroid. Patients were enrolled in the study 4-6 weeks after transplantation and were observed for 48 months. Tacrolimus trough level, total daily dose and their ratio were recorded at each of the seven follow-up visits, during the 48 months study period. Epidemiology data, patient characteristics, blood parameters (including eGFR, de novo DSA, CMV and BK virus incidence), and the acute rejection episodes were monitored. Results: Mean age at enrolment was 53.35 years, males n=41 (65.08%). A steady, therapeutic maintenance trough level was achieved in both study arms. Dosing of Life-Cycle Pharma-tacrolimus required a 30% lower total daily dose compared to Immediate-release Tacrolimus to achieve the therapeutic trough level. A slow deterioration of eGFR was observed (mean decrease of 6.06 mL/min/1.73m2 over 4 years) in the Immediate-release Tacrolimus arm in contrast to the Life-Cycle Pharma tacrolimus arm, where the eGFR increased (by 4.76 mL/min/1.73m2) in 4 years period. Conclusions: Both formulations were both proper long-term immunosuppressive treatments for kidney transplant patients, maintaining a stable trough level. Life-Cycle Pharma tacrolimus might serve as a valuable choice in avoiding drug-specific side effects, reducing calcineurin-induced nephrotoxicity.