Characteristics | Standard (n = 100) | Extended (n = 100) | Total (n = 200) | P-value |
---|---|---|---|---|
Mean age at randomization, yr. (SD) | 51.6 (11.5) | 52.1 (12.7) | 51.8 (12.1) | 0.79 |
Male, n (%) | 70 (70.0) | 69 (69.0) | 139 (69.5) | 0.88 |
Country, n (%) | ||||
Australia | 28 (28.0) | 30 (30.0) | 58 (29.0) | 0.96 |
Canada | 6 (6.0) | 5 (5.0) | 11 (5.5) | |
China | 62 (62.0) | 62 (62.0) | 124 (62.0) | |
New Zealand | 4 (4.0) | 3 (3.0) | 7 (3.5) | |
Body Mass Index (kg/m2) | 26.7 (6.1) | 25.5 (6.4) | 26.1 (6.2) | 0.16 |
Number of dialysis sessions per wk., n (%) | ||||
2 | 1 (1.0) | 1 (1.0) | 2 (1.0) | 0.30 |
3 | 82 (82.0) | 86 (86.0) | 168 (84.0) | |
≥ 4 | 17 (17.0) | 13(13.0) | 30 (15.0) | |
Total number of hr. on dialysis per wk | ||||
Median (IQR) | 12.4 (12.0–16.0) | 12.0 (12.0–15.0) | 12.0 (12.0–15.0) | 0.10 |
Duration on dialysis at enrolment, median (IQR) in yr. | 2.63 (0.97–6.74) | 2.43 (0.67–5.04) | 2.48 (0.72–6.00) | 0.37 |
Dialysis site at enrolment, n (%) | ||||
Home | 12 (12.0) | 11 (11.0) | 23 (11.5) | 0.83 |
In-centre/satellite | 88 (88.0) | 89 (89.0) | 177 (88.5) | |
Intended dialysis site for study treatment, n (%) | ||||
Home | 25 (25) | 26 (26) | 51 (25.5) | 0.87 |
In-centre/satellite | 75 (75.0) | 74 (74.0) | 149 (74.5) | |
Laboratory parameters, mean (SD) | ||||
Phosphate (mmol/L) | 1.77 (0.59) | 1.86 (0.53) | 1.82 (0.56) | 0.31 |
PTH (pmol/L) median (IQR) | 20.7 (10.9–43.5) | 28.5 (11.7–46.2) | 24.0 (11.3–46.0) | 0.33 |
Corrected Calcium (mmol/L) | 2.28 (0.24) | 2.27 (0.20) | 2.28 (0.22) | 0.72 |
Albumin (g/L) | 39.0 (4.5) | 39.0 (4.7) | 39.0 (4.6) | 0.96 |
Phosphate binder use, n (%) | ||||
Calcium-based | 57 (57) | 61 (61) | 118 (59) | 0.28 |
Non-calcium based | 11 (11) | 7 (7) | 18 (9) | |
Both non-calcium and calcium based | 12 (12) | 6 (6) | 18 (9) | |
No binder | 20 (20) | 26 (26) | 46 (23) | |
Phosphate binder burden (pills/day), median (IQR) | 3.5 (1.5–6) | 3 (0–6) | 3 (1–6) | 0.21 |
Cinacalcet use, n (%) | 4 (4.1) | 7 (7.0) | 11 (5.6) | 0.37 |
Calcitriol and analogues, n (%) | ||||
No vitamin D | 45 (46) | 48 (48) | 93 (47.0) | 0.37 |
Calcitriol/Alfacalcidiol | 47 (48) | 49 (49) | 96 (48.5) | |
Cholecalciferol | 6 (6) | 2 (2) | 8 (4.0) | |
Both | 0 (0) | 1 (1) | 1 (0.5) | |
Dialysate calcium (mmol/L), n (%) | ||||
Low (≤1.3) | 36 (36.0) | 32 (32.0) | 68 (34.0) | 0.63 |
Mid (1.5) | 58 (58.0) | 64 (64.0) | 122 (61.0) | |
High (≥1.6) | 6 (6.0) | 4 (4.0) | 10 (5.0) |