TABLE 1.
Key results from ferric derisomaltose trials in the US
| Parameter | FERWON‐IDA | FERWON‐NEPHRO | PHOSPHARE a | |||
|---|---|---|---|---|---|---|
| FDI (N = 1009) | IS (N = 503) | FDI (N = 1027) | IS (N = 511) | FDI (N = 123) | FCM (N = 122) | |
| Serious or severe hypersensitivity reaction, % | 0.3 | 0.4 | 0.3 | 0 | 0.8 | 1.7 |
| Hypophosphatemia, % | 3.9 | 2.3 | 3.2 | 0.8 | 7.9/8.1 | 75.0/73.7 |
| Severe hypophosphatemia, % | 0 | 0 | 0 | 0 | 0 | 11.3 |
| Composite cardiovascular events, % | 0.8 | 1.2 | 4.1 | 6.9 | NR | NR |
| Hb change from baseline at week 8, LS Mean g/dL | 2.49 | 2.49 | 1.22 | 1.14 | NR | NR |
Abbreviation: NR, not reported.
a
Pooled data from two PHOSPHARE trials except for the primary endpoint, percent with hypophosphatemia, which is shown for trials A and B.