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. 2023 Feb 3;24(3):3037. doi: 10.3390/ijms24033037

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.