Table 1.
Baseline demographic and clinical characteristics.
| Hexasodium fytate (n = 37) | Placebo (n = 34) | Total (n = 71) | |
|---|---|---|---|
| Mean age, SD | 57.7 (12.1) | 57.2 (11.3) | 57.5 (11.7) |
| Female sex | 23 (62%) | 21 (62%) | 44 (62%) |
| Race | |||
| White | 20 (54%) | 18 (53%) | 38 (54%) |
| Black or African American | 14 (38%) | 12 (35%) | 26 (37%) |
| Other | 3 (8%) | 4 (12%) | 7 (10%) |
| Region | |||
| North America | 32 (86%) | 32 (94%) | 64 (90%) |
| Europe | 5 (14%) | 2 (6%) | 7 (10%) |
| Mean BMI (kg/m2), SD | 33.2 (9.3) | 34.3 (9.0) | 33.7 (9.2) |
| Mean time on haemodialysis (years), SD | 5.0 (5.1) | 4.6 (4.7) | 4.8 (4.9) |
| Mean time since ESKD diagnosis (years), SD | 5.7 (4.9) | 4.9 (4.5) | 5.3 (4.7) |
| Use of other medications at baselinea | |||
| Sodium thiosulphate | 26 (68%) | 23 (70%) | 49 (69%) |
| Calcimimetics | 20 (53%) | 16 (48%) | 36 (51%) |
| Non–calcium-based phosphate binder | 29 (76%) | 26 (79%) | 55 (78%) |
| Calcium-based phosphate binder | 8 (21%) | 8 (24%) | 16 (23%) |
| Vitamin D compound | 16 (42%) | 20 (61%) | 36 (51%) |
| Warfarin | 4 (11%) | 4 (12%) | 8 (11%) |
| Opioids | 25 (66%) | 25 (76%) | 50 (70%) |
| Mean baseline BWAT-CUA scoreb (8–40), SD | 18.9 (5.3) | 20.8 (5.0) | 19.8 (5.2) |
| Mean baseline Pain VAS score (0–100), SD | 67.0 (27.0) | 71.3 (29.0) | 69.1 (27.9) |
BMI, body mass index; BWAT, Bates-Jensen Wound Assessment Tool; CUA, calcific uraemic arteriolopathy; ESKD, end-stage kidney disease; SD, standard deviation; VAS, visual analogue scale.
Data are presented as n (%).
a
Percentages for baseline medication use were calculated for the safety analysis population (n = 38 hexasodium fytate; n = 33 placebo).
b
Baseline values for each component of the BWAT are provided in the Supplementary materials.