TABLE 1.
Characteristics of included trials.
| Authors (study year) | Study design | Registration number | Diagnosis of patients | Duration of treatment | Intervention (dosage) | Control | Sample size (intervention/control) | Main outcome measurement |
|---|---|---|---|---|---|---|---|---|
| Pergola et al. (2016) | RCT | NCT01906489 | NDD-CKD | 20 weeks | Vadadustat (150–600 mg) | Placebo | 210 (138/72) | Hb response, ∆Hb, iron metabolism parameters, AEs, SAEs, rescue therapy |
| Martin et al. (2017) | RCT | NCT01381094 | NDD-CKD | 6 weeks | Vadadustat (240,370,500,630 mg) | Placebo | 91 (72/19) | Hb response, ∆Hb, iron metabolism parameters, AEs, SAEs |
| Nangaku et al. (2020) | RCT | NCT03054337 | NDD-CKD | 16 weeks a | Vadadustat (150,300,600 mg) | Placebo | 51 (37/14) | ∆Hb, iron metabolism parameters, AEs, SAEs, rescue therapy |
| RCT | NCT03054350 | DD-CKD | 16 weeks a | Vadadustat (150,300,600 mg) | Placebo | 60 (45/15) | ∆Hb, iron metabolism parameters, AEs, SAEs, rescue therapy | |
| Chertow et al. (2021) | Open-label RCT | NCT02648347 | NDD-CKD (ESA-untreated patients) | 52 weeks | Vadadustat (150∼600 mg) | Darbepoetin alfa | 1751 (879/872) | Hb response, ∆Hb, AEs, SAEs, rescue therapy |
| Open-label RCT | NCT02680574 | NDD-CKD (ESA-treated patients) | 52 weeks | Vadadustat (150∼600 mg) | Darbepoetin alfa | 1725 (862/863) | Hb response, ∆Hb, AEs, SAEs, rescue therapy | |
| Eckardt et al. (2021) | Open-label RCT | NCT02865850 | Incident DD-CKD b | 52 weeks | Vadadustat (150∼600 mg) | Darbepoetin alfa | 369 (181/188) | Hb response, ∆Hb, iron metabolism parameters, AEs, SAEs, rescue therapy |
| Open-label RCT | NCT02892149 | Prevalent DD-CKD c | 52 weeks | Vadadustat (150∼600 mg) | Darbepoetin alfa | 3,554 (1777/1777) | Hb response, ∆Hb, iron metabolism parameters, AEs, SAEs, rescue therapy | |
| Nangaku et al. (2021a) | Open-label RCT | NCT03329196 | NDD-CKD | 52 weeks | Vadadustat (150∼600 mg) | Darbepoetin alfa | 304 (151/153) | Hb response, ∆Hb, iron metabolism parameters, AEs, SAEs |
| Nangaku et al. (2021b) | RCT | NCT03439137 | DD-CKD | 52 weeks | Vadadustat (150∼600 mg) | Darbepoetin alfa | 323 (162/161) | Hb response, ∆Hb, iron metabolism parameters, AEs, SAEs |
Abbreviations: CKD, chronic kidney disease; RCT, randomized controlled trial; NDD-CKD, nondialysis-dependent chronic kidney disease; DD-CKD, dialysis-dependent chronic kidney disease; ESAs, erythropoiesis-stimulating agents; ∆Hb, change in Hb level from baseline; AEs, adverse events; SAEs, serious adverse events.
6 weeks of fixed vadadustat doses, but over the next 10 weeks, placebo patients switched to vadadustat 150, 300 or 600 mg.
Incident DD-CKD, patients were to have initiated dialysis within 16 weeks before screening and were to have had limited exposure to ESAs.
Prevalent DD-CKD, patients were undergoing maintenance dialysis for at least 12 weeks before screening and were to have been receiving treatment with an ESA.