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Abstract: PO2638

Rituximab vs. Cyclophosphamide in the Treatment of Membranous Nephropathy: The RI-CYCLO Trial

Session Information

Category: Glomerular Diseases

  • 1203 Glomerular Diseases: Clinical, Outcomes, and Trials


  • Delbarba, Elisa, ASST Spedali Civili di Brescia, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia, Lombardia, IT, public/health, Brescia, Lombardia, Italy
  • Santoro, Domenico, University of Messina, Universita degli Studi di Messina, Messina, Sicilia, IT, academic, Messina, Sicilia, Italy
  • Gesualdo, Loreto, Azienda Ospedale Policlinico, Bari, Puglia, Italy
  • Pani, Antonello, Azienda Ospedaliera Brotzu, Cagliari, Sardegna, Italy
  • Alberici, Federico, Universita degli Studi di Brescia, Brescia, Lombardia, Italy
  • Ghiggeri, Gian Marco, Istituto Giannina Gaslini, Genova, Liguria, Italy
  • Ravani, Pietro, University of Calgary, Calgary, Alberta, Canada
  • Scolari, Francesco, Universita degli Studi di Brescia, Brescia, Lombardia, Italy

Guidelines for membranous nephropathy (MN) management recommend cyclical corticosteroid-cyclophosphamide regimen (CYC) in patients with heavy proteinuria. Rituximab (RTX) may be a viable alternative, but head-to-head comparison is lacking.


Aim of this pilot RCT was to estimate the effects of RTX vs CYC regimen in MN, while assessing the feasibility of a larger trial. After a run-in of at least 3 months, patients with nephrotic syndrome were randomized to receive RTX (1g two weeks apart) or CYC. Complete remission (CR) was defined as proteinuria ≤0.3 g/day, partial remission (PR) as a reduction of proteinuria >50% and an absolute value of 0.3-3.5 g/day. Primary outcome was CR at 12 months; secondary outcomes included CR+PR at 12 and 24 months.


116 pts were screened, 74 randomized. Baseline median serum albumin was 2 g/dL and proteinuria 6 g/day in both arms. At 12 months, 6/37 pts (16%) in the RTX arm and 12/37 (32%) in the CYC arm had CR (OR according to “intention to treat_ITT” analysis 0.4, 95% CI, 0.13-1.23, OR “according to per protocol_PP“0.28, 95% CI, 0.08-0.95), 23/37 (62%) in the RTX arm and 27/37 (73%) in the cyclical regimen arm had a CR+PR (OR ITT analysis 0.61, 95% CI 0.23-1.63, OR PP 1.11, 95% CI 0.42-2.98). Probabilities of CR and CR+PR at 24 months were 0.42 (CI 0.26-0.62) and 0.83 (CI 0.65-0.95) in the RTX arm and 0.43 (0.28-0.61) and 0.82 (0.68-0.93) in the CYC arm. Serious adverse events occurred in 7 and 5 pts, in the RTX and CYC arm, respectively.


Although the probability of CR was lower in the RTX arm at 12 months, the probability of CR at 24 months and of CR+PR at 12 and 24 months was similar in the two groups. No difference in side effects was found. While the efficacy of RTX and CYC in MN appears to be similar, a larger trial adequately powered would be difficult to perform.