Aim: Tacrolimus is a calcineurin inhibitor that has been increasingly used in transplant medicine. However, the efficacy and safety of combined therapy of low-dose tacrolimus and prednisone in the treatment of nephrotic syndrome (NS) with slight mesangial proliferation has not been reported.
Patients and methods: Sixty patients with NS with slight mesangial proliferation were randomly divided into a prednisone therapy group (control), a combined low-dose tacrolimus (2 mg/day) and a prednisone therapy group (tacrolimus group). The efficacy and safety of tacrolimus was analysed. The initial dose of prednisone was 1 mg/kg per day and 30 mg/day in the control group and tacrolimus group, respectively. The duration of treatment was 6 months.
Results: After a 6-month trial of combined low-dose tacrolimus and prednisone, complete remission was achieved in 29 patients (96.66%) and partial remission in one patient (3.33%). In the control group, complete remission was achieved in 27 patients (90%) and partial remission in three patients (10%). A significant improvement in proteinuria levels was observed in the tacrolimus group compared with the control group, starting at the second week and remaining throughout the study period. Furthermore, a significant improvement in serum albumin levels was observed in the tacrolimus group compared with the control group, starting at the first month and remaining until the third month. The main side-effect was obesity (100%) and acne (46.66%) in the control group. However, these adverse events were not observed in the tacrolimus group.
Conclusion: The results demonstrated that combined therapy of low-dose tacrolimus and prednisone is an effective and safe therapeutic method for NS with slight mesangial proliferation.