Analysis of the primary and secondary endpoints was performed in a hierarchical manner – if at any point statistical significance is not met, subsequent endpoints could not be considered significant.2
Renal Response (RR) at Week 104||
eGFR ≥60 mL/min/1.73m2 or eGFR no worse than 20% below the pre-flare value; and uPCR ≤0.7; and not a treatment failure.†
Renal response was determined by reproducible changes in proteinuria and renal function at Weeks 100 and 104.
Complete Renal Response (CRR) at Week 104
eGFR ≥90 mL/min/1.73m2 or eGFR no worse than 10% below the pre-flare value; and uPCR <0.5; and not a treatment failure.†
Renal Response (RR) at Week 52
eGFR ≥60 mL/min/1.73m2 or eGFR no worse than 20% below the pre-flare value; and uPCR ≤0.7; and not a treatment failure†
Time to renal-related event or death
First instance of ESKD, doubling of serum creatinine, renal worsening (increased proteinuria and/or impaired renal function), renal disease-related treatment failure, or death.¶
eGFR = estimated glomerular filtration rate; ESKD= end-stage kidney disease; uPCR = urinary protein creatinine ratio.
|| RR is equivalent to PERR (primary efficacy renal response).
¶ Treatment failures were defined as patients who received prohibited therapy due to inadequate lupus nephritis control or renal flare management.