Transplant Trial Watch

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].

This study aimed to evaluate long‐term graft survival in kidney transplant recipients, treated with once‐daily prolonged‐release tacrolimus‐based therapy. Secondary objectives included evaluation of the long‐term impact of prolonged‐release tacrolimus on patient survival, renal function, and acute rejections (ARs).

This was a long-term, non-interventional, follow-up of the ADHERE study to assess prolonged-release tacrolimus-based immunosuppression.

Patients were eligible for this study if they had received a kidney transplant and had been assigned to prolonged‐release tacrolimus as participants of the ADHERE study. 587 patients from the ADHERE study were prospectvely followed up to assess long-term, immunosuppression.

Outcomes being assessed included: 5-year acute rejection-free survival rate, biopsy-confirmed acute rejection-free survival rate, renal function and eGFR.

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.

Jadad score

Data analysis
Modified intention-to-treat analysis

Allocation concealment

Trial registration - NCT01363752

Funding source
Industry funded