Clinical Outcomes and Quality of Life in Older De Novo Kidney Transplant Recipients Under Once-Daily Tacrolimus Formulations: The BITACORA Study.

INTRODUCTION

Although advanced age is no longer a contraindication for renal transplantation, real-world data on elderly transplant recipients remain limited.

METHODS

This multicenter, prospective study enrolled de novo kidney transplant recipients aged 60 years or older receiving once-daily tacrolimus immunosuppression, following recovery of renal function and referral to the transplant clinic. The primary objective was to describe clinical characteristics and post-transplant outcomes over a 12-month follow-up. Secondary objectives included assessing changes in quality of life and the relationship between biopsy-proven acute rejection (BPAR) and tacrolimus levels.

RESULTS

Of 280 evaluable patients, 239 completed the 12-month follow-up (mean recipient age: 69.8 years; mean donor age: 69.1 years) and 41 (14.6%) terminated due to graft loss (13, 31.7%), tacrolimus termination (12, 29.3%), death (10, 24.4%), loss to follow-up (3, 7.3%), other (2, 4.9%), and temporary tacrolimus interruption (1, 2.4%). BPAR occurred in 8.2% of patients who showed significantly higher tacrolimus levels vs those without BPAR over the follow-up (9.8 ng/mL vs. 8.9 ng/mL; p = 0.01). Opportunistic infections were reported in 78.3% patients with BPAR vs 58.8% without BPAR (p = 0.07). Quality of life improved across different domains of the Kidney Transplant Questionnaire and the ESRD-SCL.

CONCLUSION

This study monitored clinical outcomes during the first year post-transplant in older de novo kidney transplant recipients receiving grafts from older donors and under a once-daily tacrolimus-based immunosuppressive regimen. The incidence of BPAR, graft loss, and mortality was low, and patients generally experienced an improvement in quality of life, indicating an effective and safe procedure in this population.