Table 1.
Baseline demographics and disease characteristics of patients from the ITT population enrolled in the extended-release calcifediol (ERC) treatment arms of the phase 3 clinical trials or included in the MBD-AWARE ERC cohort [29–31]
| Phase 3 clinical trials | Real-world dataset | ||
|---|---|---|---|
| CTAP101-CL-3001 | CTAP101-CL-3002 | MBD-AWAREa (n = 174) | |
| ERC (n = 141) | ERC (n = 144) | ||
| Patient demographics | |||
| Age, years, mean (SD) | 65.1 (10.3) | 66.8 (10.9) | 69.0 (13.2) |
| Male, n (%) | 70.0 (49.6) | 73.0 (50.7) | 84.0 (48.3) |
| Race, n (%) | |||
| White | 85 (60.3) | 98 (68.1) | 113 (64.9) |
| Black or African-Americanb | 50 (35.5) | 43 (29.9) | 34 (19.5) |
| Other | 6 (4.2) | 2 (1.4) | 19 (10.9) |
| Not available | 0.0 | 1 (0.7) | 8 (4.6) |
| Body mass index, kg/m2, mean (SD) | 34.1 (8.3) | 34.7 (7.9) | 34.2 (20.7) |
| CKD characteristics | |||
| CKD stage, n (%) | |||
| 3 | 71 (50.4) | 80 (55.6) | 81 (46.6) |
| 4 | 70 (49.6) | 64 (44.4) | 93 (53.4) |
| Primary cause of CKD, n (%) | |||
| Hypertension | 54 (38.3) | 49 (34.0) | 36 (20.7) |
| Diabetes | 55 (39.0) | 74 (51.4) | 30 (17.2) |
| Other | 5 (3.5) | 5 (3.5) | 3 (1.7) |
| Unknown cause | 27 (19.1) | 16 (11.1) | 105 (60.3) |
| Laboratory parameters | |||
| Serum calcium, mg/dL, mean (SD) | 9.2 (0.29) | 9.3 (0.35) | 9.2 (1.3) |
| Serum phosphorus, mg/dL, mean (SD) | 3.7 (0.55) | 3.8 (0.56) | 3.8 (1.3) |
| Plasma iPTH, pg/mL, mean (SD) | 146.8 (56.01) | 147.6 (64.21) | 181.4 (97.6) |
| eGFR, mL/min/1.73 m2, mean (SD) | 30.3 (11.07) | 30.9 (9.90) | 31.1 (14.5) |
| Serum 25(OH)D, ng/mL, mean (SD) | 20.2 (5.08) | 19.7 (5.56) | 20.3 (9.2) |
25(OH)D, 25-hydroxyvitamin D; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; ERC, extended-release calcifediol; iPTH, intact parathyroid hormone; NVD, nutritional vitamin D; 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.
bOnly includes African-American patients in the MBD-AWARE cohort.