Table 1.
Patient demographics and baseline characteristics (mITT population)
| Placebo (n = 5) |
Atacicept 25 mg (n = 6) |
Atacicept 75 mg (n = 5) |
|
|---|---|---|---|
| Age (years), mean ± SD | 46 ± 3.1 | 41 ± 16.9 | 43 ± 8.9 |
| Female, n (%) | 1 (20) | 5 (83) | 2 (40) |
| Race, n (%) | |||
| White | 4 (80) | 5 (83) | 2 (40) |
| Black | 0 | 0 | 0 |
| Asian | 1 (20) | 1 (17) | 1 (20) |
| Other | 0 | 0 | 2 (40) |
| Ethnicity, Hispanic, n (%) | 0 | 1 (17) | 3 (60) |
| Time since diagnosis (years), median (Q1, Q3) | 1.26 (1.05, 12.42) | 2.17 (0.12, 2.99) | 2.55 (2.52, 4.62) |
| Time since most recent kidney biopsy (years), median (Q1, Q3) | 0.50 (0.31, 1.05) | 1.80 (0.12, 2.96) | 0.97 (0.33, 2.52) |
| History of tonsillectomy, n (%) | 0 | 0 | 2 (40) |
| History of systemic corticosteroids, n (%) | 1 (20) | 2 (33) | 1 (20) |
| Concomitant medications, n (%) | |||
| ACEi and/or ARB | 5 (100) | 6 (100) | 5 (100) |
| ACEi without ARB | 3 (60) | 3 (50) | 1 (20) |
| ARB without ACEi | 2 (40) | 3 (50) | 4 (80) |
| Diuretics | 0 | 3 (50) | 2 (40) |
| eGFR by CKD-EPI (ml/min per 1.73 m2), median (Q1, Q3) | 49 (48, 54) | 57 (53, 85) | 55 (52, 92) |
| Proteinuria | |||
| UPCR by 24-h urine collection (mg/mg), median (Q1, Q3) | 1.6 (1.5, 1.6) | 1.8 (0.8, 2.2) | 1.4 (1.3, 1.7) |
| Total protein by 24-hr urine collection (g/d), median (Q1, Q3) | 3.2 (2.3, 3.3) | 2.1 (1.9, 2.9) | 1.7 (1.6, 2.3) |
| Immunoglobulins | |||
| IgA (g/l), mean ± SD | 3.97 ± 1.72 | 3.58 ± 1.22 | 3.02 ± 0.85 |
| IgG (g/l), mean ± SD | 10.51 ± 2.63 | 9.45 ± 1.82 | 10.89 ± 1.10 |
| IgM (g/l), mean ± SD | 1.29 ± 0.51 | 0.90 ± 0.55 | 1.09 ± 0.30 |
| Gd-IgA1 (ng/ml), mean ± SD | 7690 ± 3642 | 6258 ± 3211 | 6052 ± 2773 |
| Complement (mg/l) | |||
| Serum C3, median (Q1, Q3) | 1330 (1180, 1520) | 1625 (1410, 1700) | 1260 (1230, 1300) |
| Serum C4, median (Q1, Q3) | 287 (282, 310) | 332 (305,370) | 379 (233, 408) |
ACEi, angiotensin-converting-enzyme inhibitor; ARB, angiotensin receptor blocker; CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; eGFR, estimated glomerular filtration rate; Gd-IgA1, galactose-deficient IgA1; mITT, modified intent-to-treat; Q1/3, quartile 1/3; UPCR, urine protein:creatinine ratio.