Table 1.

Demographics, baseline characteristics, and laboratory values (MITT population)

Variable10,000 IU QW (n = 39)20,000 IU Q2W (n = 76)20,000 IU Q4W (n = 72)40,000 IU Q4W (n = 72)All (n = 259)
Age (yr; mean ± SD)65.2 ± 11.167.8 ± 13.667.8 ± 14.466.9 ± 13.667.1 ± 13.5
Sex (n [%])
    women25 (64.1)43 (56.6)40 (55.6)44 (61.1)152 (58.7)
    men14 (35.9)33 (43.4)32 (44.4)28 (38.9)107 (41.3)
Race (n [%])
    white21 (53.8)43 (56.6)33 (45.8)43 (59.7)140 (54.1)
    black9 (23.1)16 (21.1)21 (29.2)18 (25.0)64 (24.7)
    Hispanic6 (15.4)12 (15.8)10 (13.9)10 (13.9)38 (14.7)
    Asian3 (7.7)4 (5.3)6 (8.3)1 (1.4)14 (5.4)
    other01 (1.3)2 (2.8)03 (1.2)
BMI (kg/m2; mean ± SD)30.6 ± 7.129.3 ± 7.730.3 ± 7.330.9 ± 7.930.2 ± 7.6
Hb (g/dl; mean ± SD)10.3 ± 0.710.4 ± 0.810.1 ± 1.010.2 ± 0.910.2 ± 0.9
GFR (ml/min per 1.73 m2; mean ± SD)29.9 ± 10.531.0 ± 14.029.9 ± 12.029.7 ± 13.630.2 ± 12.8
BUN (mg/dl; mean ± SD)14.1 ± 5.615.4 ± 6.915.6 ± 6.215.3 ± 6.315.2 ± 6.3
Primary cause of CKD (n [%])
    diabetes24 (61.5)32 (42.1)34 (47.2)41 (56.9)131 (50.6)
    hypertension11 (28.2)32 (42.1)27 (37.5)22 (30.6)92 (35.5)
    glomerular disease1 (2.6)3 (3.9)6 (8.3)4 (5.6)14 (5.4)
    cystic kidney disease02 (2.6)002 (0.8)
    congenital01 (1.3)01 (1.4)2 (0.8)
    other3 (7.7)6 (7.9)5 (6.9)4 (5.6)18 (6.9)
  • QW, once weekly; Q2W, every 2 wk; Q4W, every 4 wk; BMI, body mass index; Hb, hemoglobin; GFR, glomerular filtration rate; BUN, blood urea nitrogen; CKD, chronic kidney disease.