Table 1.
Baseline characteristics of two clinical trials of IL-1 inhibition in CKD
| Variable | Study A | Study B | ||
|---|---|---|---|---|
| CKD Stages 3 and 4, n=16 | Maintenance Hemodialysis | |||
| IL-1 Trap, n=16 | Placebo, n=16 | IL-1ra, n=7 | Placebo, n=7 | |
| Demographics | ||||
| Men, n (%) | 11 (69) | 12 (75) | 5 (71) | 5 (71) |
| Age, yr, mean±SD | 62±12 | 67±8 | 51±14 | 48±12 |
| Black race, n (%) | 4 (25) | 4 (25) | 6 (86) | 4 (57) |
| Clinical characteristics | ||||
| Statin, n (%) | 8 (50) | 12 (75) | NA | NA |
| Diabetes, n (%) | 8 (50) | 9 (56) | 0 (0) | 3 (43) |
| BMI, kg/m2, mean±SD | 32±6.2 | 31±5 | 34±6 | 29±10 |
| Inflammatory biomarkers | ||||
| Serum albumin, g/dl | 4.0 (3.7, 4.0) | 3.9 (3.7, 4.1) | 4.1 (3.7, 4.3) | 3.8 (3.6, 4.5) |
| Plasma hsCRP, mg/L | 4.2 (2.1, 7.9) | 4.2 (1.45, 5.5) | 9.5 (6.8, 12.6) | 19.5 (5.2, 21.3) |
| Plasma IL-6, pg/ml | 1.6 (0.9, 2.3) | 1.6 (1.2, 3.6) | 4.6 (4.4, 8.4) | 6.2 (1.8, 17.2) |
| Plasma TNF-α, pg/ml | 1.7 (1.3, 3.4) | 2.1 (1.7, 3.6) | 21.6 (20.1, 23.1) | 20.7 (12.3, 66.6) |
| Lipids | ||||
| HDL, mg/dl | 43 (35, 60) | 37 (31, 40) | 47 (45, 50) | 39 (35, 42) |
| LDL, mg/dl | 83 (71, 123) | 78 (72, 97) | 95 (87, 100) | 65 (39, 78) |
| Triglycerides, mg/dl | 115 (72, 144) | 147 (97, 184) | 104 (94, 130) | 203 (132, 267) |
| Total cholesterol, mg/dl | 162 (129, 190) | 143 (134, 179) | 160 (158, 169) | 145 (126, 166) |
Statistical comparison done using chi-squared test for categorical variables and Kruskal–Wallis for continues variables. Data for inflammatory biomarkers and lipids is displayed as median (interquartile range). IL-1ra, IL-1 receptor antagonist; NA, not applicable; BMI, body mass index; hsCRP, high-sensitivity C-reactive protein.