Table 3.
Comparison of Changes in Clinical Parameters and CKD-MBD Medication Use
| Parameter | Baseline (−Q1; ref) | SO Therapy |
||||
|---|---|---|---|---|---|---|
| Q1 | Q2 | Q3 | Q4 | P Value | ||
| CKD-MBD biochemical markers | ||||||
| Serum phosphorus (mg/dL) | 6.82 (0.05) | 6.54 (0.05)*** | 6.37 (0.05)*** | 6.25 (0.05)*** | 6.19 (0.05)*** | <.0001 |
| Serum phosphorus ≤5.5 mg/dL (%) | 17.7 | 24.5*** | 30.5*** | 36.4*** | 36.0*** | <.0001 |
| Corrected calcium (mg/dL)† | 9.25 (0.03) | 9.21 (0.03)* | 9.16 (0.03)*** | 9.16 (0.03)*** | 9.1 (0.03)*** | <.0001 |
| iPTH (pg/mL) | 611 (23) | 627 (23) | 622 (23) | 636 (23) | 643 (23)* | .16 |
| CKD-MBD medications | ||||||
| Phosphate binder pills/day | 8.5 (0.08) | 4.0 (0.07)*** | 4.1 (0.07)*** | 4.2 (0.07)*** | 4.3 (0.07)*** | <.0001 |
| Cinacalcet use (%) | 38.5 | 40.8* | 44.2*** | 45.7*** | 46.0*** | <.0001 |
| Cinacalcet dose (mg/day) | 60.1 (4.1) | 63.4 (4.1)** | 63.9 (4.1)*** | 63.0 (4.1)* | 62.0 (4.1) | .0002 |
| IV active vitamin D‡ use (%) | 74.2 | 69.6* | 62.5*** | 53.4*** | 43.2*** | <.0001 |
| IV doxercalciferol dose (mcg/week) | 3.7 (0.1) | 3.9 (0.1)* | 4.0 (0.1)** | 4.2 (0.1)*** | 4.3 (0.1)*** | <.0001 |
| Oral active vitamin D§ use (%) | 15.7 | 24.2*** | 34.5*** | 42.6*** | 47.2*** | <.0001 |
| Oral calcitriol dose (mcg/week) | 0.62 (0.03) | 0.65 (0.02)* | 0.70 (0.02)*** | 0.75 (0.02)*** | 0.84 (0.02)*** | <.0001 |
| Nutritional and clearance parameters | ||||||
| Serum albumin (g/dL) | 3.96 (0.01) | 3.97 (0.01) | 3.97 (0.01) | 3.95 (0.01) | 3.92 (0.01)*** | <.0001 |
| Phosphorus-attuned albumin, ×103 | 0.62 (0.01) | 0.65 (0.01)*** | 0.68 (0.01)*** | 0.69 (0.01)*** | 0.69 (0.01)*** | <.0001 |
| Predialysis weight (kg) | 90.3 (1.0) | 90.8 (1.0)*** | 90.9 (1.0)*** | 90.8 (1.0)*** | 90.7 (1.0)*** | <.0001 |
| nPCR (g/kg/day) | 0.96 (0.01) | 0.96 (0.01) | 0.95 (0.01) | 0.94 (0.01)* | 0.94 (0.01)** | .002 |
| Phosphorus-attuned nPCR, ×103 dL/kg/day | 0.15 (0.002) | 0.16 (0.002)*** | 0.16 (0.002)*** | 0.16 (0.002)*** | 0.16 (0.002)*** | <.0001 |
| Equilibrated Kt/V | 1.46 (0.01) | 1.47 (0.01) | 1.46 (0.01) | 1.47 (0.01) | 1.46 (0.01) | .23 |
CKD-MBD, chronic kidney disease–related mineral and bone disorders; iPTH, intact parathyroid hormone; IV, intravenous; nPCR, normalized protein catabolic rate; ref, referent; SO, sucroferric oxyhydroxide.
Values are presented as least-squared mean (standard error). P values compare summary estimates across time with −Q1 as the reference. Overall P values were calculated using linear mixed effects regression (continuous variables) or Cochran’s Q test (categorical variables).
P < .05
P < .001
P < .0001 (vs. baseline).
Corrected calcium = serum calcium + [0.0176 × (34 − serum albumin)].
IV vitamin D use includes doxercalciferol, calcitriol, and paricalcitol.
Oral vitamin D use includes calcitriol and doxercalciferol.