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Kidney Week

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

Authors

  • 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
Background

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.

Methods

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.

Results

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.

Conclusion

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.