Laboratory test results, ITT population
Category (normal cut-off value) | Baseline, mean (SD) | Month 6, mean (SD) | Month 12, mean (SD) | Month 24, mean (SD) | p Value (baseline vs Month 24) |
---|---|---|---|---|---|
White blood cell count (3.5×109/L) | |||||
Normal at baseline (×109/L) | 6.5 (2.12), n=271 | 6.4 (2.02), n=271 | 6.3 (2.08), n=276 | 6.4 (2.14), n=276 | 0.5173 |
Abnormal (low) at baseline (×109/L) | 2.7 (0.51), n=94 | 3.7 (1.41), n=94 | 4.0 (1.19), n=94 | 4.1 (1.58), n=94 | <0.0001 |
Haemoglobin (male=13.5 g/dL, female=12 g/dL) | |||||
Normal/high at baseline (g/dL) | 13.3 (0.90), n=171 | 13.1 (1.03), n=171 | 13.1 (0.99), n=176 | 13.1 (1.02), n=176 | 0.1051 |
Abnormal (low) at baseline (g/dL) | 10.9 (0.95), n=193 | 11.4 (1.01), n=193 | 11.6 (1.06), n=193 | 11.6 (1.13), n=193 | <0.0001 |
Platelet count (150×109/L) | |||||
Normal/high at baseline (×109/L) | 262.5 (80.39), n=276 | 252.7 (69.47), n=276 | 251.9 (68.62), n=280 | 250.5 (72.11), n=280 | 0.0355 |
Abnormal (low) at baseline (×109/L) | 105.0 (26.55), n=88 | 131.8 (41.77), n=88 | 145.8 (49.29), n=88 | 155.9 (54.04), n=89 | <0.0001 |
ESR (male <50 years=15 mm/h, male ≥50 years and female <50 years=20 mm/h, female ≥50 years=30 mm/h) | |||||
Normal/high at baseline (mm/h) | 12.7 (7.44), n=56 | 13.9 (9.68), n=56 | 12.5 (10.04), n=60 | 10.0 (6.65), n=60 | 0.0225 |
Abnormal (elevated) at baseline (mm/h) | 48.7 (20.98), n=273 | 32.1 (17.4), n=273 | 26.4 (16.86), n=277 | 25.0 (17.56), n=280 | <0.0001 |
Serum creatinine (male=1.3 mg/dL, female=1.1 mg/dL) | |||||
Normal/low at baseline (mg/dL) | 0.8 (0.18), n=284 | 0.8 (0.19), n=284 | 0.8 (0.18), n=291 | 0.9 (0.22), n=296 | 0.6660 |
Abnormal (high) at baseline (mg/dL) | 1.6 (0.63), n=56 | 1.4 (0.53), n=56 | 1.3 (0.47), n=59 | 1.3 (0.48), n=59 | <0.0001 |
Spot urine protein–creatinine ratio (0.2 mg/mg) | |||||
Normal at baseline (mg/mg) | 0.1 (0.04), n=40 | 0.1 (0.04), n=40 | 0.1 (0.05), n=41 | 0.1 (0.14), n=46 | 0.1880 |
Abnormal (high/very high) at baseline (mg/mg) | 0.8 (0.78), n=41 | 0.7 (0.65), n=41 | 0.6 (0.71), n=53 | 0.5 (0.53), n=58 | <0.0001 |
24 h urine collection (normal to high 300 mg/24 h, high to very high 500 mg/24 h) | |||||
Normal at baseline (mg/24 h) | 283.0 (0), n=1 | 257.0 (0), n=1 | 209.0 (0), n=1 | 207 (132.28), n=3 | 0.7500 |
Abnormal (high) at baseline (mg/24 h) | 417.8 (61.9), n=5 | 450.0 (119.79), n=5 | 714.3 (454.96), n=6 | 688.3 (477.47), n=6 | 0.3125 |
Abnormal (very high) at baseline (mg/24 h) | 1014.0 (466.9), n=4 | 839.5 (225.7), n=4 | 1643.8 (1344.2), n=5 | 1466.9 (1242.3), n=7 | 1.0000 |
CRP (10 mg/L) | |||||
Normal at baseline (mg/L) | 1.8 (1.68), n=246 | 1.0 (1.07), n=246 | 1.0 (1.97), n=253 | 0.8 (0.9), n=260 | 0.0156 |
Abnormal (elevated) at baseline (mg/L) | 16.2 (4.77), n=7 | 7.6 (4.42), n=7 | 5.3 (7.34), n=7 | 5.3 (8.45), n=7 | <0.0001 |
AST (male=20 IU/L, female=36 IU/L) | |||||
Normal/low at baseline (IU/L) | 21.8 (6.60), n=243 | 23 (9.46), n=243 | 23.2 (9.93), n=248 | 23.8 (9.55), n=248 | 0.0025 |
Abnormal (high) at baseline (IU/L) | 43.9 (17.26), n=56 | 32.6 (13.76), n=56 | 33.2 (16.77), n=59 | 31.2 (16.06), n=60 | <0.0001 |
ALT (male=45 IU/L, female=33 IU/L) | |||||
Normal/low at baseline (IU/L) | 20.6 (6.70), n=236 | 21.3 (7.93), n=236 | 21.6 (9.23), n=244 | 22.3 (8.69), n=246 | 0.0159 |
Abnormal (high) at baseline (IU/L) | 46.9 (15.44), n=70 | 36.6 (17.31), n=70 | 35 (18.13), n=72 | 33.2 (17.71), n=73 | <0.0001 |
C3 complement (75 mg/dL) | |||||
Normal/high at baseline (mg/dL) | 114.4 (30.03), n=142 | 119.1 (28.98), n=142 | 120.1 (27.90), n=148 | 118.7 (28.68), n=150 | 0.0244 |
Abnormal (low) at baseline (mg/dL) | 53.3 (16.68), n=136 | 70.3 (25.39), n=136 | 80.2 (28.01), n=142 | 82.2 (32.21), n=145 | <0.0001 |
C4 complement (male=12 mg/dL, female=13 mg/dL) | |||||
Normal/high at baseline (mg/dL) | 25.5 (13.54), n=122 | 26.9 (13.03), n=122 | 26.7 (11.94), n=128 | 27.6 (12.08), n=130 | 0.0012 |
Abnormal (low) at baseline (mg/dL) | 7.4 (3.04), n=156 | 12.8 (7.46), n=156 | 14.5 (7.60), n=162 | 16.2 (9.20), n=165 | <0.0001 |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; ITT, intent-to treat.