Tacrolimus in the treatment of HBV associated membranous nephropathy: a randomized controlled trial

Abstract

Objective To conduct a prospective, randomly controlled trial, evaluating the combination of tacrolimus, corticosteroids and entecavir for the treatment of adult patients with biopsy-proven hepatitis B virus-associated membrane nephropathy (HBV-MN). Methods A total of 38 patients with biopsy-confirmed HBV-MN were randomized to the tacrolimus group (n=19) and the control group (n=19). Patients in tacrolimus group received combination therapy of tacrolimus (0.05 mg·kg-1·d-1), corticosteroids (prednisone acetate, 0.5 mg·kg-1·d-1) and entecavir (0.5 mg/d), whereas patients in control group received entecavir mono-therapy (0.5 mg/d). The primary end point was the percentage of patients reaching complete remission (CR) or partial remission (PR). Results The probability of remission in the treatment group was 88.89% and 94.44% after 6 and 12 months, but only 38.89% and 58.82% in the control group, respectively. The decrease in proteinuria was significantly greater in the treatment group. Entecavir was used for the treatment of hepatitis in all patients, which caused the disappearance of serum hepatitis B viral DNA(HBV-DNA) and the normalization of ALT and AST levels in 3 months. Notably, two patients in the control group and one patient in the treatment group reached the secondary end point. One patient in the tacrolimus-treated group showed a relapse during the taper period. Conclusion This treatment protocol not only can control the replication of HBV-DNA but also can reduce proteinuria and preserve renal function, it is one of useful therapeutic options for patients with HBV-MN. Key words: Tacrolimus; Glucocorticoids; Hepatitis B virus; Glomerulonephritis, membranous; Entecavir