Tacrolimus combined with corticosteroids in idiopathic membranous nephropathy: a randomized, prospective, controlled trial.

Although idiopathic membranous nephropathy (IMN) is the most common cause of adult-onset nephrotic syndrome, the management of IMN remains controversial. The aim of this prospective study was to compare the efficacy and drug safety of tacrolimus with that of cyclophosphamide (CTX; control group) in IMN patients receiving corticosteroid therapy. A total of 100 IMN patients with nephrotic syndrome were randomly assigned to receive a combination of corticosteroid therapy and either CTX or tacrolimus. During a follow-up period of at least 18 months, the remission rate after 2 months in the tacrolimus group was 65.1%, which was higher than that of the CTX group (44.2%) (p = 0.02). The mean time to partial or complete remission was 2.20 months in the tacrolimus group and 3.92 months in the CTX group (p < 0.001). We also found significantly greater improvements in the serum albumin levels in the tacrolimus group compared with the CTX group at the 2-month (p = 0.003) and 3-month time points (p = 0.01). The serum creatinine levels remained stable in both groups. Although remission was quicker and more common in the tacrolimus group (compared with the CTX group) before 3 months, there was no superiority of tacrolimus after 6 months. Glucose intolerance, urinary tract infections, and pneumonia were the major side effects observed in this study. All of the side effects were mild and controlled, and there were fewer side effects in the tacrolimus group compared with the CTX group, indicating a better treatment tolerance in the tacrolimus group.

RCT Entities:   Population Interventions Outcomes