ParameterCCX168+CYC+Low-Dose SteroidsCCX168+CYC+No SteroidsStandard of Care: CYC+High-Dose Steroids
(N=8)(N=8)(N=9)
Demographics and baseline characteristics
 Age, mean (SD); Male/Female (%)55 (15); 50:5058 (14); 50:5055 (16); 70/30
 Newly diagnosed/relapsing disease (%)75/2587.5/12.570/30
 MPO/PR3+ ANCA (%)62.5/37.550/37.540/60
 BVAS version 3, mean (SD)13 (8)14 (8)9 (4)
 eGFR, mL/min/1.73 m2, mean (SD)52 (18)57 (25)57 (15)
Efficacy results
 Steroid rescue events01 (13%)1 (11%)
 Renal remission*6 (75%)5 (63%)4 (44%)
 U-ACR mean % change**−63%−59%−9%
 eGFR mean (SE) change (mL/min/1.73 m2)6.8 (2.1)0.6 (3.6)2.2 (3.3)
 Urinary MCP-1/creatinine mean % change**−72%−52%−37%
 BVAS mean (SE) % change**−71 (9)%−65 (11)%−26 (25)%

  • ↵* Renal remission is defined as a reduction from baseline in urinary RBCs and improvement in renal function based on eGFR.

  • ↵** Based on ratio of geometric means of Wk12:Baseline.