Table 5.
Treatment effect on mineral metabolism and kidney function, one-way ANOVA with repeated measures or Friedman test
| Treatment group | Week 0 | Week 4 | Week 8 | P value for time effect | Difference Week 0 versus week 4 |
Difference Week 0 versus week 8 |
|---|---|---|---|---|---|---|
| Placebo | ||||||
| eGFR (ml/min) | 29.6 ± 14.4 | 28.1 ± 13.6 | 29.6 ± 12.6 | 0.38 | −1.5 (−5.1 to 2.1) | 0.0 (−3.7 to 3.7) |
| ionCa (mmol/l) | 1.210 ± 0.054 | 1.206 ± 0.017 | 1.230 ± 0.041 | 0.84 | −0.005 (−0.046 to 0.036) | −0.007 (−0.044 to 0.029) |
| sPO4 (mmol/l) | 1.040 ± 0.202 | 1.118 ± 0.246 | 1.050 ± 0.258 | 0.33 | 0.078 (−0.054 to 0.210) | 0.010 (−0.115 to 0.135) |
| uPO4 (mg/d) | 2428 ± 751 | 2588 ± 860 | 2458 ± 365 | 0.82 | 159 (−854 to 1173) | 30 (−651 to 711) |
| PTH (pmol/l) | 10.4 (6.5:16.8) | 8.3 (7.0:16.9) | 11.6 (7.1:23.3) | 0.26 | −2.1 | 1.2 |
| 25-D3 (nmol/l) | 61.0 (48.5; 78.5) | 66.5 (53.3; 78.0) | 60.5 (56.3; 72.8) | 0.34 | 5.5 | −0.5 |
| FGF-23 (IU) | 98.0 (54.3; 173.8) | 153.0 (68.3; 277.0) | 112.0 (60.5; 357.3) | 0.56 | 55 | 14 |
| QTc (ms) | 408.3 ± 25.7 | 413.7 ± 19.7 | 414.8 ± 14.9 | 0.74 | 5.4 (−23.5 to 34.3) | 6.5 (−17.7 to 30.7) |
| Mg 15 mmol/d | ||||||
| eGFR (ml/min) | 36.2 ± 12.8 | 38.6 ± 15.1 | 36.6 ± 14.0 | 0.17 | 2.5 (−1.8 to 6.7) | 0.4 (−3.2 to 3.9) |
| ionCa (mmol/l) | 1.193 ± 0.048 | 1.191 ± 0.041 | 1.179 ± 0.050 | 0.45 | −0.002 (−0.030 to 0.026) | −0.014 (−0.055 to 0.027) |
| sPO4 (mmol/l) | 1.082 ± 0.239 | 1.085 ± 0.234 | 1.085 ± 0.188 | 0.99 | 0.003 (−0.197 to 0.202) | 0.003 (−0.232 to 0.238) |
| uPO4 (mg/d) | 2281 ± 880 | 2381 ± 647 | 2450 ± 1045 | 0.64 | 100 (−414 to 614) | 169 (−353 to 691) |
| PTH (pmol/l) | 9.3 (4.5; 18.3) | 10.1 (5.3; 13.9) | 13.8 (5.7; 17.3) | 0.34 | 0.8 | 4.5 |
| 25-D3 (nmol/l) | 46.5 (35.5; 65.3) | 49.0 (35.8; 54.8) | 40.5 (33.8; 63.3) | 0.67 | 3.5 | −6 |
| FGF-23 (IU) | 62 (53; 112) | 58 (42; 105) | 59 (56; 111) | 0.61 | −4 | −3 |
| QTc (ms) | 421.2 ± 30.3 | 418.5 ± 23.1 | 415.9 ± 30.9 | 0.73 | −2.7 (−17.2 to 11.8) | −5.3 (−27.8 to 17.2) |
| Mg 30 mmol/d | ||||||
| eGFR (ml/min) | 32.3 ± 8.4 | 32.6 ± 9.6 | 31.8 ± 9.6 | 0.86 | −0.3 (−3.7 to 3.1) | 0.5 (−3.6 to 4.5) |
| ionCa (mmol/l) | 1.20 ± 0.04 | 1.21 ± 0.04 | 1.22 ± 0.06 | 0.18 | −0.01 (−0.04 to 0.02) | −0.03 (−0.08 to 0.03) |
| sPO4 (mmol/l) | 1.09 ± 0.18 | 1.09 ± 0.19 | 1.05 ± 0.20 | 0.62 | −0.00 (−0.08 to 0.08) | 0.04 (−0.10 to 0.18) |
| uPO4 (mg/d) | 2126 ± 537 | 2027 ± 741 | 2071 ± 726 | 0.86 | 99 (−577 to 774) | 55 (−366 to 476) |
| PTH (pmol/l) | 13.2 (3.3; 17.9) | 15.1 (3.4; 19.9) | 13.0 (5.8; 15.5) | 0.81 | 1.9 | −0.2 |
| 25-D3 (nmol/l) | 63.5 (44.3; 81.0) | 64.0 (39.3; 79.3) | 58.0 (40.8; 73.0) | 0.38 | 0.5 | −5.5 |
| FGF-23 (IU) | 75 (62; 110) | 69 (57; 93) | 72 (47; 96) | 0.40 | −6 | −3 |
| QTc (ms) | 427.6 ± 21.2 | 430.3 ± 22.3 | 418.3 ± 26.0 | 0.03∗ | −2.8 (−16.4 to 10.9) | −9.2 (−4.8 to 23.3) |
Reported as mean ± SD or median and interquartile range for weeks 0, 4, and 8 (as relevant), and change with 95% confidence interval or absolute change for differences between time points (as relevant).
ANOVA, analysis of variance; 25-D3, 25-hydroxy vitamin D3; CI, confidence interval; ionCa, ionized calcium; sCa, total serum calcium; eGFR, estimated glomerular filtration rate; FGF-23, intact fibroblast growth factor 23; Mg, magnesium; sPO4, serum phosphate; PTH, parathyroid hormone; uPO4, urine phosphate; QTc, corrected QT interval.
∗
P < 0.05.