Table 1.
Major randomized clinical trials (RCTs) on membranous nephropathy since 2019.
| Study | MENTOR [7] | STARMEN [8] | RI-CYCLO [9] |
|---|---|---|---|
| Design | Multicenter North America N = 130 |
Multicenter Europe N = 86 |
Multicenter Italy+Switzerland N = 74 |
| Inclusion | Proteinuria > 5 g/24 h CrCI > 40 mL/min/1.73 m2 |
Proteinuria > 4 g/24 h eGFR > 45 mL/min/1.73 m2 |
Proteinuria > 3.5 g/24 h eGFR ≥ 30 mL/min/1.73 m2 |
| PLA2R positivity | 74% (96/130) |
77% (53/69) |
66% (59/73) |
| Run-in | 3 months | 6 months | 3 months |
| Comparison | Rituximab vs. Cyclosporine |
Modified Ponticelli (Methylprednisolone + cyclophosphamide) vs. tacrolimus + rituximab |
Modified Ponticelli (Methylprednisolone + cyclophosphamide) vs. Rituximab |
| Remission definition | CR: proteinuria < 0.3 g/24 h, Alb > 3.5 g/dL PR: proteinuria 50% reduction from baseline + range between 0.3–3.5 g/24 h Relapse: proteinuria > 3.5 g/24 h after CR or PR |
CR: proteinuria < 0.3 g/24 h, eGFR > 45 mL/min PR: same as MENTOR, eGFR > 45 mL/min Relapse: same as MENTOR |
Same as MENTOR |
| Outcome CR + PR (CR only) |
12 months | ||
| 60% vs. 52% | 79% vs. 51% | 73% vs. 62% (32% vs. 16%) | |
| 24 months | |||
| 60% vs. 20% (35% vs. 0%) | 84% vs. 58% (60% vs. 26%) | 81% vs. 85% (35% vs. 42%) | |
| SAE | 17% vs. 31% | 19% vs. 14% | 14% vs. 19% |
Results of outcome are given by Intention-To-Treat; PR, partial remission; SAE, severe adverse events.