Long-term, prolonged-release tacrolimus-based immunosuppression in de novo kidney transplant recipients: 5-year prospective follow-up of the ADHERE study patients.
Rummo, O., Carmellini, M. et al. (2019).Transplant International [record in progress].
Aims
This study aimed to evaluate longâ€term graft survival in kidney transplant recipients, treated with onceâ€daily prolongedâ€release tacrolimusâ€based therapy. Secondary objectives included evaluation of the longâ€term impact of prolongedâ€release tacrolimus on patient survival, renal function, and acute rejections (ARs).
Interventions
This was a long-term, non-interventional, follow-up of the ADHERE study to assess prolonged-release tacrolimus-based immunosuppression.
Participants
Patients were eligible for this study if they had received a kidney transplant and had been assigned to prolongedâ€release tacrolimus as participants of the ADHERE study. 587 patients from the ADHERE study were prospectvely followed up to assess long-term, immunosuppression.
Outcomes
Outcomes being assessed included: 5-year acute rejection-free survival rate, biopsy-confirmed acute rejection-free survival rate, renal function and eGFR.
Follow-up
5 years
CET Conclusions
The paper reports the long-term follow up of the ADHERE trial that compared prolonged-release tacrolimus with either MMF or sirolimus in de novo adult kidney transplant patients and the primary outcome of the analysis was long-term graft survival. The 1-year ADHERE trial randomised 730 patients and the 4-year non-interventional follow up was completed by 510 patients. At one-year posttransplant the overall graft survival rate was 93% and at 5 years posttransplant the overall graft survival rate was 84% and similar between the two study arms (89.3% for the MMF arm and 87.6% for the sirolimus arm). The patient survival rate was 97.8% at 1 year posttransplant and 90.8% at 5 years posttransplant (91.9% for the MMF arm and 93.3% for the sirolimus arm). Renal function was stable throughout the study period and there were no differences in the adverse events between study arms.
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT01363752