Table 2.
Characteristics of participants in cinacalcet and control groups at baseline, and week 12 of follow-up in phase 1.
| Phase 1 of study | Control (N = 15) | Cinacalcet (N = 15) | p-Value |
|---|---|---|---|
| Age (mean ± SD, years) | 49.4 ± 10.2 | 49.5 ± 11.9 | .99 |
| Male (number (%)) | 7 (47%) | 12 (80%) | .06 |
| Hemodialysis duration (mean ± SD, years) | 7.1 ± 5.0 | 6.6 ± 3.6 | .75 |
| Baseline | |||
| • Serum calcium (mean ± SD, mg/dL) | 10.0 ± 0.7 | 9.8 ± 0.7 | .41 |
| • Serum phosphate (mean ± SD, mg/dL) | 4.8 ± 2.0 | 4.4 ± 1.4 | .45 |
| • Serum iPTH (pg/mL) | 1374 (955, 1639) | 1191 (1005, 1884) | .11* |
| • Serum 25(OH) (mean ± SD, ng/mL) | 26.5 ± 13.2 | 22.9 ± 11.8 | .44 |
| • Serum FGF-23 (pg/mL) | 1692 (652, 3958) | 1434 (180, 4980) | .74 |
| • Serum TRAP-5b (u/L) | 1.2 (0.6, 2.0) | 1.7 (0.4, 4.2) | .37 |
| • Serum albumin (mean ± SD, g/dL) | 4.3 ± 0.4 | 4.5 ± 0.5 | .17 |
| • Dialysate calcium (mean ± SD, mEq/L) | 2.5 ± 0.0 | 2.6 ± 0.3 | .19 |
| • Oral medication calcium treatment (mean ± SD, mg/d) | 943 ± 562 | 1117 ± 508 | .62 |
| • Active vitamin D supplement (mean ± SD, ug/week) | 3.5 ± 3.1 | 3.3 ± 0.9 | .67 |
| Week 12 | |||
| • Serum calcium ( mean ± SD, mg/dL) | 10.3 ± 0.7 | 8.5 ± 0.9 | <.001 |
| • Serum phosphate ( mean ± SD, mg/dL) | 4.6 ± 1.1 | 3.9 ± 1.4 | .12 |
| • Serum iPTH (pg/mL) | 1199 (918, 1877) | 565 (184, 1067) | .022* |
| • Serum 25(OH) (mean ± SD, ng/mL) | 26.0 ± 4.9 | 23.0 ± 8.6 | .25 |
| • Serum FGF-23 (pg/mL) | 1252 (294, 2371) | 243 (34, 555) | .043* |
| • Serum TRAP-5b (u/L) | 1.9 (1.0, 3.6) | 1.7 (0.1, 2.9) | .70 |
| • Serum albumin ( mean ± SD, g/dL) | 4.3 ± 0.4 | 4.2 ± 0.5 | .83 |
| • Dialysate calcium ( mean ± SD, mEq/L) | 2.5 ± 0.0 | 3.0 ± 0.5 | .001 |
| • Oral medication calcium treatment ( mean ± SD, mg/d) | 760 ± 410 | 1185 ± 341 | .04 |
| • Active vitamin D supplement (mean ± SD, ug/week) | 3.5 ± 2.9 | 3.3 ± 1.0 | .85 |
25(OH): 25-hydroxy vitamin D; FGF-23: fibroblast growth factor 23; iPTH: intact parathyroid hormone; TRAP-5b: tartrate-resistant acid phosphatase 5b *nonparametric Mann-Whitney U-test.