Outcome Measures
Primary and Secondary Endpoints
Complete Renal Response (CRR) at month 24 from baseline, defined as
- UPCR ≤ 0.5 g/g in two consecutive first-morning void urine specimens; and
- no increase in serum creatinine by ≥ 25% from baseline.
1. Renal function impairment at month 60, defined as a sustained (e. observed in at least two consecutive measurements on different dates) increase in serum creatinine by ≥ 25% from baseline.
2. Renal relapse (proteinuric flare) defined as reappearance of UPCR > 1.0 g/g from month 12 onwards, leading to intensification or change of immunosuppressive therapy. This increased proteinuria has to be sustained (e. observed in at least two consecutive measurements on different dates), occurring after an initial response to induction therapy (defined as sustained UPCR < 0.5 g/g).
3. Reabsorption of immune deposits in repeat kidney biopsies, defined as ≥ 50% decrease in intensity and amount of immune deposits in electron microscopy.
4. End-stage kidney disease (ESKD).
5. Death.
2. Renal relapse (proteinuric flare) defined as reappearance of UPCR > 1.0 g/g from month 12 onwards, leading to intensification or change of immunosuppressive therapy. This increased proteinuria has to be sustained (e. observed in at least two consecutive measurements on different dates), occurring after an initial response to induction therapy (defined as sustained UPCR < 0.5 g/g).
3. Reabsorption of immune deposits in repeat kidney biopsies, defined as ≥ 50% decrease in intensity and amount of immune deposits in electron microscopy.
4. End-stage kidney disease (ESKD).
5. Death.