Table 2.
Pre- and post-treatment measurements of 25-hydroxyvitamin D, iPTH, calcium, phosphorus, and estimated glomerular filtration rate in patients from the ITT population treated with extended-release calcifediol (ERC) in the phase 3 clinical trials or included in the MBD-AWARE ERC cohort [34–36]
| Phase 3 clinical trials | Real-world dataset | |||||
|---|---|---|---|---|---|---|
| CTAP101-CL-3001 | CTAP101-CL-3002 | MBD-AWAREa (n = 174) | ||||
| ERC (n = 141) | ERC (n = 144) | |||||
| pre | post | pre | post | pre | post | |
| Serum 25(OH)D, ng/mL, mean | 20.2 (SD: 5.08) | 67.0 (SD: 22.25)b | 19.7 (SD: 5.56) | 66.8 (SD: 21.41)c | 20.3 (SE: 0.7) | 44.0 (SE: 1.7) |
| Plasma iPTH, pg/mL, mean | 146.8 (SD: 56.01) | 109.6 (SD: 50.95)d | 147.6 (SD: 64.21) | 113.1 (SD: 76.29)c | 181.4 (SE: 7.4) | 147.4 (SE: 7.1) |
| Serum calcium, mg/dL, mean | 9.2 (SD: 0.29) | 9.4 (SD: 0.49)e | 9.3 (SD: 0.35) | 9.4 (SD: 0.35)f | 9.2 (SE: 0.1) | 9.3 (SE: 0.1) |
| Serum phosphorus, mg/dL, mean | 3.7 (SD: 0.55) | 3.9 (SD: 0.62)e | 3.8 (SD: 0.56) | 4.0 (SD: 0.68)f | 3.8 (SE: 0.1) | 3.9 (SE: 0.1) |
| eGFR, mL/min/1.73 m2, mean | 30.3 (SD: 11.07) | 29.8 (SD: 11.84)e | 31.0 (SD: 9.93)g | 29.4 (SD: 11.51)h | 31.1 (SE: 1.1) | 28.0 (SE: 0.9) |
25(OH)D, 25-hydroxyvitamin D; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; ERC, extended-release calcifediol; iPTH, intact parathyroid hormone; ITT, intention-to-treat; NVD, nutritional vitamin D; PP, per protocol; SD, standard deviation; VDA, vitamin D analogues.
aThe MBD-AWARE study included 374 patients in total. In addition to the ERC cohort shown, 55 patients were included in the VDA cohort and 147 patients were included in the NVD cohort.
b n = 118.
c n = 124.
d n = 117.
e n = 131.
f n = 136.
g n = 143.
h n = 132.