Conversion from calcineurin inhibitors to sirolimus maintenance therapy in renal allograft recipients: 24-month efficacy and safety results from the CONVERT trial.

摘要: Background The efficacy and safety of converting maintenance renal transplant recipients from calcineurin inhibitors (CNIs) to sirolimus (SRL) was evaluated. Methods Eight hundred thirty allograft recipients, 6 120 months posttransplant receiving cyclosporine or tacrolimus, were randomly assigned continue CNI (n=275) convert SRL (n=555). Primary endpoints calculated Nankivell glomerular filtration rate (GFR; stratified at baseline: 20-40 vs. >40 mL/min) the cumulative rates biopsy-confirmed acute rejection (BCAR), graft loss, death 12 months. Enrollment in 20 40 mL/min stratum halted prematurely because a higher incidence conversion arm. Results Intent-to-treat analyses 24 showed no significant treatment difference GFR baseline more than stratum. On-therapy analysis this cohort significantly after conversion. Rates BCAR, survival, patient survival similar between groups. Median urinary protein-to-creatinine ratios (UPr/Cr) but increased Malignancy lower Post hoc identified subgroup with UPr/Cr less equal 0.11, whose risk-benefit profile favorable that for overall cohort. Conclusions At 2 years, among patients associated excellent protein excretion, malignancy compared continuation. Superior function observed who remained on through months, particularly 0.11.