Treatment group | 0X | 1X | 3X | 5X | ||
---|---|---|---|---|---|---|
Dose (loading+maintenance) | (Placebo) | (8 + 4 mg/kg) | (24 + 12 mg/kg) | (40 + 20 mg/kg) | Pa | |
Alkaline phosphatase (U/L) | Basal | 73 (24) | 65 (11) | 63 (9) | 60 (15) | ns |
(ALP) | Week 4 | 103 (46) | 70 (16) | 86 (37) | 88 (27) | ns |
Week 8 | 95 (35) | 74 (19) | 87 (32) | 125 (39) | ns | |
Week 13 | 99 (34) | 74 (23) | 88 (34) | 95 (18) | ns | |
Week 17 | 97 (34) | 75 (25) | 86 (31) | ns | ||
Week 21 | 95 (41) | 77 (26) | 87 (40) | ns | ||
Week 25 | 88 (34) | 69 (28) | 85 (33) | ns | ||
Week 30 | 86 (41) | 76 (31) | 84 (37) | ns | ||
Alanine aminotransferase (U/L) | Basal | 24 (7) | 24 (6) | 32 (17) | 30 (9) | ns |
(ALT) | Week 4 | 27 (6) | 30 (6) | 30 (5) | 33 (8) | ns |
Week 8 | 30 (6) | 30 (6) | 30 (6) | 31 (7) | ns | |
Week 13 | 35 (11) | 35 (8) | 37 (4) | 39 (10) | ns | |
Week 17 | 35 (11) | 33 (6) | 35 (7) | ns | ||
Week 21 | 30 (9) | 31 (5) | 34 (7) | ns | ||
Week 25 | 30 (8) | 32 (8) | 35 (7) | ns | ||
Week 30 | 35 (10) | 33 (6) | 35 (7) | ns | ||
Aspartate aminotransferase (U/L) | Basal | 34 (7) | 30 (6) | 32 (5) | 34 (6) | ns |
(AST) | Week 4 | 36 (9) | 34 (4) | 37 (6) | 39 (11) | ns |
Week 8 | 34 (7) | 32 (3) | 34 (6) | 34 (6) | ns | |
Week 13 | 40 (8) | 35 (5) | 48 (5) | 40 (6) | ns | |
Week 17 | 41 (10) | 37 (5) | 39 (9) | ns | ||
Week 21 | 35 (6) | 36 (4) | 38 (6) | ns | ||
Week 25 | 35 (5) | 35 (6) | 42 (7) | ns | ||
Week 30 | 37 (8) | 39 (5) | 42 (5) | ns | ||
Urea (mmol/L) | Basal | 5,5 (0,7) | 5,5 (0,6) | 5,8 (1,1) | 5,5 (0,8) | ns |
Week 4 | 5,8 (0,9) | 6,4 (0,9) | 7,4 (1,0) | 7,9 (1,7)* | ||
Week 8 | 5,8 (1,1) | 6,5 (1,3) | 7,3 (1,0) | 8,3 (1,8)* | ||
Week 13 | 4,6 (0,7) | 5,0 (0,5) | 6,0 (0,9)* | 6,9 (0,9)** | ||
Week 17 | 6,4 (0,8) | 7,3 (1,3) | 8,4 (2,1)* | |||
Week 21 | 6,3 (1,2) | 6,1 (0,9) | 7,4 (0,9) | ns | ||
Week 25 | 5,7 (0,6) | 6,3 (1,0) | 7,2 (1,3)* | |||
Week 30 | 5,4 (0,7) | 6,5 (0,8) | 7,2 (1,2)** | |||
Creatinine (μmol/L) | Basal | 51 (6) | 52 (7) | 59 (8) | 58 (7) | ns |
Week 4 | 54 (3) | 54 (5) | 58 (7) | 59 (6) | ns | |
Week 8 | 53 (9) | 56 (5) | 58 (7) | 60 (6) | ns | |
Week 13 | 54 (4) | 50 (10) | 55 (9) | 60 (8) | ns | |
Week 17 | 54 (4) | 51 (7) | 55 (9) | ns | ||
Week 21 | 56 (7) | 53 (7) | 59 (10) | ns | ||
Week 25 | 53 (3) | 53 (7) | 57 (7) | ns | ||
Week 30 | 60 (4) | 58 (6) | 63 (10) | ns | ||
Total Protein (g/L) | Basal | 55 (3) | 54 (2) | 55 (3) | 54 (1) | ns |
Week 4 | 57 (3) | 54 (3) | 53 (4) | 52 (2) | ns | |
Week 8 | 53 (3) | 53 (2) | 51 (3) | 51 (2) | ns | |
Week 13 | 58 (3) | 54 (3) | 55 (2) | 54 (1) | ns | |
Week 17 | 57 (3) | 54 (1) | 53 (3) | ns | ||
Week 21 | 56 (3) | 54 (3) | 52 (3) | ns | ||
Week 25 | 58 (2) | 56 (3) | 53 (3) | ns | ||
Week 30 | 58 (2) | 55 (4) | 53 (3) | ns | ||
Albumin (g/L) | Basal | 32 (2) | 32 (1) | 32 (2) | 32 (2) | ns |
Week 4 | 32 (2) | 31 (1) | 30 (2) | 30 (2) | ns | |
Week 8 | 32 (1) | 32 (2) | 31 (2) | 30 (1) | ns | |
Week 13 | 34 (2) | 31 (2) | 32 (2) | 32 (1) | ns | |
Week 17 | 33 (2) | 32 (2) | 33 (2) | ns | ||
Week 21 | 33 (1) | 32 (2) | 31 (2) | ns | ||
Week 25 | 32 (1) | 31 (2) | 30 (2) | ns | ||
Week 30 | 34 (1) | 32 (2) | 31 (2) | ns | ||
Cholesterol (mmol/L) | Basal | 3,6 (0,6) | 4,0 (0,5) | 3,3 (0,4) | 3,5 (0,4) | ns |
Week 4 | 4,3 (0,5) | 4,9 (0,9) | 4,4 (0,7) | 5,1 (0,8) | ns | |
Week 8 | 4,0 (0,6) | 4,8 (0,7) | 4,4 (0,7) | 5,4 (1,4) | ns | |
Week 13 | 4,1 (0,6) | 4,4 (0,7) | 5,1 (1,2)* | 5,5 (1,1)** | ||
Week 17 | 3,5 (0,6) | 3,9 (0,6) | 4,4 (1,0) | ns | ||
Week 21 | 4,2 (0,9) | 4,8 (0,8) | 4,6 (0,7) | ns | ||
Week 25 | 4,4 (0,9) | 4,7 (0,9) | 4,4 (0,7) | ns | ||
Week 30 | 3,9 (0,7) | 4,7 (1,3) | 4,6 (0,7) | ns |