Table 3.
Demographic and clinical characteristics of patients in multiple-dose study
| Groups |
Placebo (M1+M2) | Cohort M1 |
Cohort M2 |
|
|---|---|---|---|---|
| Dose | 2.5 mg/person | 5 mg/person | ||
| No. of patients, n | 6 | 8 | 8 | |
| Sex | Male | 2 (33.3%) | 4 (50.0%) | 3 (37.5%) |
| Female | 4 (66.7%) | 4 (50.0%) | 5 (62.5%) | |
| Age (yr) | Mean ± SD | 54.2 ± 16.9 | 64.4 ± 9.4 | 54.0 ± 14.6 |
| Median | 54.0 | 61.5 | 53.5 | |
| Range | 30–74 | 54–81 | 37–83 | |
| Body weight (kg) (postdialysis) | Mean ± SD | 52.13 ± 6.56 | 48.05 ± 11.47 | 63.88 ± 18.52 |
| Median | 48.80 | 46.25 | 63.90 | |
| Range | 46.3–60.5 | 33.2–67.4 | 38.9–88.4 | |
| BMI (kg/m2) | Mean ± SD | 21.16 ± 1.21 | 19.63 ± 2.83 | 25.16 ± 6.09 |
| Median | 20.99 | 18.74 | 23.69 | |
| Range | 19.6–22.9 | 16.5–24.2 | 17.0–35.9 | |
| Duration of dialysis (yr) | Mean ± SD | 8.2 ± 5.6 | 13.1 ± 6.2 | 9.6 ± 6.0 |
| Median | 8.0 | 11.0 | 10.0 | |
| Range | 1–17 | 7–24 | 2–21 | |
| Active vitamin D treatment | Yes | 4 (66.7%) | 7 (87.5%) | 7 (87.5%) |
| No | 2 (33.3%) | 1 (12.5%) | 1 (12.5%) | |
| Phosphate binder treatment | Yes | 5 (83.3%) | 8 (100.0%) | 8 (100.0%) |
| No | 1 (16.7%) | 0 (0.0%) | 0 (0.0%) | |
| Serum iPTH (pg/ml) | Mean ± SD | 636.7 ± 183.0 | 695.0 ± 345.7 | 453.5 ± 127.5 |
| Median | 655.5 | 556.5 | 415.0 | |
| Range | 350–813 | 408–1420 | 341–726 | |
| Serum cCa (mg/dl) | Mean ± SD | 9.62 ± 0.79 | 9.80 ± 0.50 | 10.20 ±0.79 |
| Median | 9.25 | 9.75 | 10.05 | |
| Range | 9.0–10.9 | 9.2–10.7 | 9.4–11.8 | |
| Serum P (mg/dl) | Mean ± SD | 4.95 ± 0.80 | 5.48 ± 1.35 | 5.36 ± 1.22 |
| Median | 4.95 | 5.35 | 5.60 | |
| Range | 4.0–5.8 | 3.9–7.5 | 3.3–6.9 | |
| Serum BAP (μg/l)a | Mean ± SD | 27.90 ± 7.26 | 35.58 ± 40.78 | 17.30 ± 9.68 |
| Median | 27.55 | 21.85 | 15.70 | |
| Range | 20.2–40.2 | 10.8–135.0 | 8.0–37.3 | |
| Serum TRACP-5b (mU/dl)a | Mean ± SD | 821.0 ± 178.1 | 697.6 ± 355.8 | 548.5 ± 297.7 |
| Median | 838.5 | 572.0 | 488.0 | |
| Range | 504–1050 | 328–1390 | 188–1090 | |
| Serum FGF23 (pg/ml)a (logarithm) | Mean ± SD | 7.81 ± 1.53 | 8.66 ± 2.31 | 9.54 ± 1.64 |
| Median | 7.96 | 9.64 | 9.67 | |
| Range | 5.7–10.2 | 5.5–11.0 | 6.6–11.8 | |
BAP, bone alkaline phosphatase; BMI, body mass index; cCa, albumin-corrected Ca; FGF23, fibroblast growth factor−23; iPTH, serum intact parathyroid hormone; M, multiple-dose; P, phosphorus; TRACP-5b, tartrate-resistant acid phosphatase−5b.
a
Data obtained for baseline measurements.