Table 3:

Clinical trials of newly-approved and emerging drug targets and their endpoints

Drug	Trial	Phase	Treatment	Primary Endpoint	Secondary Endpoint
Belimumab	BLISS-LN	III	IV belimumab (10mg/kg) vs placebo + standard therapy	Primary efficacy renal response at 104 weeks: uPCR≤0.7, eGFR≤20% below baseline or ≥60ml/min/1.73m2, no rescue therapy	CRR at 104 weeks: uPCR<0.5 eGFR≤10% below baseline or ≥90ml/min/1.73m2 no rescue therapy
Voclosporin	AURA-LV	II	Voclosporin 23.7 mg BID vs. 39.5 mg BID vs. matched placebo + MMF (2 g/d) + rapidly tapered corticosteroids	CRR at 24 weeks: uPCR≤0.5 eGFR<20% below baseline or >60ml/min/1.73m2 No rescue therapy	CRR at 48 weeks
Voclosporin	AURORA-1	III	Voclosporin 23.7 mg BID vs. placebo + MMF (2g/d) + rapidly tapered low oral corticosteroids	CRR at 52 weeks: uPCR≤0.5 eGFR<20% below baseline or >60ml/min/1.73m2 no rescue therapy	Time to uPCR≤0.5, Partial renal response (PRR) (≥50% reduction from baseline eGFR) Time to 50% reduction in uPCR CRR at 24 weeks
Obinutuzumab	NOBILITY	II	IV obinutuzumab 1000mg vs. placebo on day1 and weeks 2, 24, 26 + MMF + corticosteroids	CRR at 52 weeks: uPCR<0.5 serum creatinine ≤ULN and <15% below baseline inactive urinary sediment (<10 RBC/HPF, no RBC casts) no rescue therapy	PRR at 52 weeks: ≥50% reduction in uPCR ≤15% increase in serum creatinine from baseline, urinary RBC<10/HPF or ≤50% from baseline