Multitarget therapy with a corticosteroid, cyclosporine and mycophenolate mofetil for idiopathic membranous nephropathy: a prospective randomized controlled trial

Nephrol Dial Transplant. 2023 Dec 20;39(1):95-102. doi: 10.1093/ndt/gfad156.

Abstract

Background: The effectiveness of multitarget combination therapy with a corticosteroid, cyclosporine and mycophenolate mofetil for idiopathic membranous nephropathy (IMN) is unclear. In the present study, we aimed to compare the efficacy and safety of multitarget therapy with a cyclical corticosteroid-cyclophosphamide regimen in patients with IMN.

Methods: This was a single-centre, prospective, randomized, controlled trial. We randomly assigned patients with IMN to receive multitarget therapy (a combination of prednisone, cyclosporine and mycophenolate mofetil) or 6-month cyclical treatment with a corticosteroid and cyclophosphamide. The study patients were followed up for 12 months. The primary outcome was a composite of complete or partial remissions at 12 months. Adverse events were also assessed.

Results: The study cohort comprised 78 patients, 39 of whom received multitarget therapy and the other 39 cyclical alternating treatment with a corticosteroid and cyclophosphamide. At 12 months, 31 of 39 patients (79%) in the multitarget therapy group and 34 of 39 (87%) in the corticosteroid-cyclophosphamide group had achieved complete or partial remissions (relative risk 0.93; 95% confidence interval 0.72-1.21; P = .85; log-rank test). The prevalence of adverse events was significantly lower in the multitarget therapy group than in the corticosteroid-cyclophosphamide group [46% (18 of 39) vs 74% (29 of 39); P < .05].

Conclusions: Multitarget therapy for IMN patients is noninferior to cyclical alternating treatment with corticosteroid and cyclophosphamide in inducing proteinuria remission and has a better safety profile than the corticosteroid-cyclophosphamide combination.

Keywords: combination drug therapy; cyclosporine; idiopathic membranous nephropathy; mycophenolate mofetil; steroid.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adrenal Cortex Hormones / therapeutic use
  • Cyclophosphamide / therapeutic use
  • Cyclosporine* / therapeutic use
  • Drug Therapy, Combination
  • Glomerulonephritis, Membranous* / drug therapy
  • Humans
  • Immunosuppressive Agents / therapeutic use
  • Mycophenolic Acid / therapeutic use
  • Prospective Studies

Substances

  • Cyclosporine
  • Mycophenolic Acid
  • Immunosuppressive Agents
  • Cyclophosphamide
  • Adrenal Cortex Hormones