Table 2.
Summary of peer-reviewed clinical studies discussed in this review
Compound | Ref. | Pat | Durat weeks | Comp | Fe suppl | Hb | Ferritin | TIBC | TSAT | Hepcidin | Chol | VEGF |
---|---|---|---|---|---|---|---|---|---|---|---|---|
AKB-6548 Vadadustat |
86 | NDD | 20 | Placebo | Oral Fe allowed | + | ↓ | ↑ | No change | ↓ | No effect | No change |
88,89 (Meeting abstracts) |
DD convers. | 16 | None, 3 dose cohorts | i.v. Fe permitted | + | n.r.$ | n.r.$ | n.r.$ | n.r.$ | n.r.$ | n.r.$ | |
GSK-1278863 Daprodustat |
81 | NDD | 4 | Placebo | Not specified | + | ↓ | ↑* | ↓* | ↓ | ↓ | No clear change# |
DD | 4 | rhEPO | Not specified | + 5 mg only |
↓ (5 mg) |
↑* | No change (5 mg) | No change (5 mg) | ↓ | No clear change# | ||
FG-4592 Roxadustat |
83 | NDD | 4 | Placebo | i.v. Fe prohibited, oral Fe allowed | + Dose-dep. |
↓& Also placebo |
↑ | ↓ | ↓ | n.r. | n.r. |
85 | DD Incident patients |
12 | None | One i.v., 2 oral and one no-iron cohort | + Iron-indep. |
↓ | ↑ | ↓ | ↓ | n.r | n.r | |
84 | NDD | 16–24 | None, 6-cohort dose-finding study | i.v. Fe prohibited, oral Fe allowed | + Starting dose-dep. |
↓, for BL Ferritin ≥100 ng/mL |
n.r. | ↓ Initially |
↓ | ↓ | n.r. | |
82 | DD convers. |
6 or 19 | rhEPO | Oral Fe allowed, i.v. Fe as rescue | + | No change | ↑ At 6 wks |
No change | ↓ At 19 wks |
↓ | n.r. |
+ denotes effectiveness in changing or maintaining hemoglobin (Hb);
denotes trends, small, or statistically nonsignificant changes;
denotes that high interpatient variability was observed;
not statistically significant compared to placebo;
not reported in the meeting abstracts, manuscript containing iron data in preparation;
BL, base line; convers., conversion from ESA therapy to HIF-PHI; Comp, Comparator; n.r., not reported; Pat, either dialysis-dependent (DD) or nondialysis-dependent (NDD) CKD patients, incident patients are newly initiated EPO-naïve hemodialysis or peritoneal dialysis patients.