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Efficacy and Safety of Moderate-Dose Glucocorticoids with Tacrolimus in High-Risk Membranous Nephropathy: A Real-World Comparison of Three Immunosuppressive Regimens

Year: 2026

Type: article

Abstract: Objective: This study was designed to evaluate the efficacy of moderate-dose glucocorticoid (mGC) combined with tacrolimus (FK506) in high-risk patients with membranous nephropathy (MN), and compare with two widely used therapies: full-dose glucocorticoid (GC) plus cyclophosphamide (CTX), and rituximab (RTX) plus FK506, the latter being recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines. This study aims to provide evidence for individualized treatment in high-risk MN. Methods: A total of 154 patients with high-risk MN were enrolled and assigned into three treatment groups: full-dose GC combined with CTX group (GC+CTX) (n=53), mGC combined with FK506 group (mGC+FK506) (n=51), and RTX combined with FK506 group (RTX+FK506) (n=50). Baseline clinical and laboratory parameters and follow-up data at 1, 3, 6, and 12 months post-treatment were collected. Outcomes including disease remission rates, relapse rates, and adverse events were compared among the three groups. Results: At 12 months of follow-up, the overall remission rates for the GC+CTX, mGC+FK506, and RTX+FK506 groups were 94.4%, 94.1%, and 82.0%, respectively, with corresponding complete remission rates of 32.1%, 43.1%, and 24.0%. No significant intergroup differences were observed ( P > 0.05). The mGC+FK506 group demonstrated higher remission rates at both 3 and 6 months. Multivariate Cox regression indicated that baseline serum albumin > 20 g/L was a protective factor (HR = 1.638, P = 0.004), and comorbid diabetes mellitus an independent risk factor (HR = 0.617, P = 0.032). Conclusion: The mGC+FK506 regimen was non-inferior to the GC+CTX and RTX+FK506 regimens in treating high-risk MN, with an earlier onset of therapeutic effect and superior remission rates at 3 and 6 months. Early correction of hypoalbuminemia and strict glycemic control are critical for improving prognosis. This study may provide evidence for individualized treatment selection in high-risk MN patients who are intolerant to high-dose GC or have limited access to RTX. Keywords: membranous nephropathy, high-risk group, tacrolimus, glucocorticoid, efficacy

Source: Drug Design Development and Therapy

DOI: 10.2147/dddt.s639867