Table 1.

Baseline demographic clinical characteristics (full analysis set analysis population)

CharacteristicJTT-751 (n=57)Placebo (n=29)P Value
Sex, n (%)0.95a
 Men33 (57.9)17 (58.6)
 Women24 (42.1)12 (41.4)
Age, yr (mean±SD)65.3±10.264.6±13.50.78b
Primary disease of CKD, n (%)0.63a
 Chronic GN15 (26.3)10 (34.5)
 Diabetic nephropathy16 (28.1)10 (34.5)
 Nephrosclerosis7 (12.3)3 (10.3)
 Polycystic kidney disease3 (5.3)3 (10.3)
 Chronic GN and diabetic nephropathy1 (1.8)0 (0.0)
 Unknown11 (19.3)2 (6.9)
 Otherc4 (7.0)1 (3.4)
KDOQI CKD classification, n (%)0.30a
 Stage 30 (0.0)1 (3.4)
 Stage 44 (7.0)1 (3.4)
 Stage 553 (93.0)27 (93.1)
eGFR in CKD stage 5 (ml/min per 1.73 m2), n (%)0.68a
 10 to <1512 (22.6)6 (22.2)
 5 to <1038 (71.7)18 (66.7)
 <53 (5.7)3 (11.1)
Prior phosphate binder therapy, n (%)0.66a
 Calcium carbonate10 (17.5)4 (13.8)
Prior vitamin D therapy, n (%)0.95a
 Oral preparations22 (38.6)11 (37.9)
Efficacy parameters (mean±SD)
 Serum phosphate (mg/dl)5.66±0.755.57±0.630.56b
 Corrected serum calcium (mg/dl)8.61±0.528.57±0.440.72b
 Calcium–phosphate product (mg2/dl2)48.75±6.9047.68±5.280.47b
 Urinary phosphate (mg/d)d380.6 (289.8, 520)341.9 (273.6, 492.7)0.82e
 Intact PTH (pg/ml)d246 (129, 364)236 (156, 331)0.95e
 FGF-23 (pg/ml)d453 (215, 800)358 (237, 656)0.47e
  • JTT-751, ferric citrate hydrate; KDOQI, Kidney Disease Outcomes Quality Initiative; PTH, parathyroid hormone; FGF-23, fibroblast growth factor-23.

  • a Chi-squared test.

  • b t test.

  • c Other includes gouty kidney, obesity-related nephropathy, abdominal aortic aneurysm, FSGS in the JTT-751 group, and Alport’s syndrome in the placebo group.

  • d Data are expressed as median (25th, 75th percentile interval).

  • e Wilcoxon rank-sum test.