Table 3.
Global studies of HIF-PHI.
Trials | n | ESA | Comparator | Period (wks) | Ref | |
---|---|---|---|---|---|---|
Roxadustat | phase 3 | |||||
NDD | ALPS | 594 | Naïve | Placebo | 52 | [135] |
DOLOMITES | 616 | Naïve | DA | 104 | [136] | |
ANDES | 922 | Naïve | Placebo | 52–234 | [137] | |
OLYMPUS | 2781 | Naïve | Placebo | 52–208 | [138] | |
Incident DD | HIMALAYAS | 1043 | Naïve | Epoetin alfa | 52 | [139] |
DD | ROCKIES | 2133 | Naïve | Epoetin alfa | 52 | [140] |
User | ||||||
SIERRAS | 741 | User | Epoetin alfa | 52 | [141] | |
PYRENEES | 836 | User | DA or epoetin alfa | 52–104 | [142] | |
Vadadustat | phase 3 | |||||
NDD | PRO2TECT | 1751 | Naïve | DA | 52 | [143] |
1725 | User | DA | 52 | |||
Incident DD | INNO2VATE | 369 | User | DA | 52 | [144] |
DD | 3554 | User | DA | 52 | ||
Daprodustat | phase 3 | |||||
NDD | ASCEND-ND | 3872 | Naïve | DA | 52 | [145] |
DD | ASCEND-D | 2964 | User | Epoetin alfa (HD) | 52 | [146] |
Subctaneous DA (PD) | ||||||
ASCEND-ID | 312 | Limited user | DA | 52 | [147] | |
ASCEND-TD | 407 | User | Epoetin alfa | 52 | [148] | |
Molidustat | phase 2b | |||||
NDD | DIALOGUE 1 | 121 | Naïve | Placebo | 16 | [149] |
DIALOGUE 2 | 124 | User | DA | 16 | ||
HD | DIALOGUE 4 | 199 | User | Epoetin alfa/beta | 16 | |
Extension Studies | [150] | |||||
NDD | DIALOGUE 3 | 83 | Naïve | Placebo | 36 | |
77 | User | DA | 36 | |||
HD | DIALOGUE 5 | 87 | User | Epoetin alfa/beta | 36 |
DA, darbepoetin alfa; DD, dialysis dependent; ESA, erythropoiesis-stimulating agent; HD, hemodialysis; NDD, non-dialysis dependent; PD, peritoneal dialysis.