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. 2021 Mar 18;11(1):8–25. doi: 10.1016/j.kisu.2020.12.002

Table 4.

Summary of ongoing NCT-registered clinical studies of hypoxia-inducible factor–prolyl hydroxylase inhibitors in patients with anemia of CKD

Study design (identifier) Patients; target no. Comparator Primary end point(s) Completion date
Daprodustat
Phase 2, R, OL, AC, CO (ASCEND: Fe; NCT03457701) NDD-CKD; n = 12 rhEPO Fractional iron absorption Mar 19, 2021
Phase 2, R, OL, AC, PG (ASCEND-BP; NCT03029247) DD-CKD (M-HD); n = 62 Epoetin alfa Mean 6-h postdose SBP at day 57 Jul 16, 2020
Phase 3, R, DB, PC, PG (ASCEND-NHQ; NCT03409107) NDD-CKD; n = 600 PBO Mean change from baseline in Hb at weeks 24–28 Oct 6, 2020
Phase 3, R, OL, AC, PG (ASCEND-ND; NCT02876835) NDD-CKD; n = 4500 DPO
Iron
  • 1.

    Time to the first occurrence of adjudicated MACE

  • 2.

    Mean change from baseline in Hb at weeks 28–52

 Mar 17, 2022
Phase 3, R OL, AC, PG (ASCEND-ID; NCT03029208) DD-CKD (I-DD); n = 300 DPO
Iron		 Mean change from baseline in Hb at weeks 28–52 Oct 8, 2020
Phase 3, R, DB, AC, PG (ASCEND-TD; NCT03400033) DD-CKD (M-HD); n = 407 Epoetin alfa Mean change from baseline in Hb at weeks 28–52 Jun 19, 2020
Phase 3, R, OL, AC, PG (ASCEND-D; NCT02879305) DD-CKD (M-DD); n = 2986 rhEPO
  • 1.

    Time to the first occurrence of adjudicated MACE

  • 2.

    Mean change from baseline in Hb at weeks 28–52

 Nov 25, 2021
Desidustat
Phase 3, R, OL, AC, PG (DREAM-ND; NCT04012957) NDD-CKD; n = 588 DPO Mean change from baseline in Hb at week 24 Dec 30, 2020
Phase 3, R, OL, AC, PG (DREAM-D; NCT04215120) DD-CKD (M-HD); n = 392 Epoetin alfa Mean change from baseline in Hb at week 24 Nov 30, 2021
Molidustat
Phase 3, R, DB, DD, AC, PG (MIYABI HD-M; NCT03543657) DD-CKD (M-HD); n = 220 DPO
  • 1.

    Mean Hb during weeks 33–36

  • 2.

    Mean change from baseline in Hb at weeks 33–36

 Dec 24, 2019
Roxadustat
Phase 3, R, OL, AC, PG (NCT02988973) NDD-CKD; n = 334 DPO Change from baseline in mean Hb at weeks 18–24 Mar 26, 2020
Phase 4, R, OL, AC, PG (NCT04134026) DD-CKD (I-HD); n = 400 Epoetin alfa
  • 1.

    Mean change in Hb at weeks 28–52

  • 2.

    Hb response rate

  • 3.

    Incidence of CV and cerebrovascular events

 Oct 19, 2023
Phase 4, R, OL, NC, PG (NCT04059913) DD-CKD (HD or PD); n = 306 None Part 1 (weeks 1–20):
ESA-naïve: % of patients who achieve Hb ≥11.0 g/dl
ESA-treated: % of patients who achieve mean Hb ≥10.0 g/dl
Part 2 (weeks 21–36):
Mean Hb at weeks 33–37		 Nov 2021
Vadadustat
Phase 1, R, OL, AC, PG (NCT03992066) DD-CKD (M-HD); n = 35 DPO
Epoetin alfa
  • 1.

    AUClast, AUC∞, Cmax, Tmax, t½, CL/F, Vd/F for vadadustat and ESA

  • 2.

    Tmax, AUClast, AUC∞, Cmax for vadadustat metabolite(s)

  • 3.

    Serum erythropoietin level for the ESA therapy group

 Jul 2020
Phase 2, R, OL, AC, PG (FO2RWARD-2; NCT03799627) DD-CKD (M-HD); n = 125 Epoetin alfa Mean change from baseline in Hb at weeks 10–12 Jul 2020

AC, active controlled; AUC∞, area under the concentration-time curve from 0 to infinity; AUClast, area under the concentration-time curve from 0 to last quantifiable concentration; CKD, chronic kidney disease; CL/F, apparent clearance; Cmax, peak plasma concentration; CV, cardiovascular; DB, double blind; DPO, darbepoetin alfa; DD, dialysis dependent; ESA, erythropoietin-stimulating agent; Fe, iron; Hb, hemoglobin; HD, hemodialysis; I-DD, incident dialysis (HD or PD); I-HD, incident HD; MACE, major adverse CV event; M-DD, maintenance/stable dialysis (HD or PD); M-HD, maintenance HD; NC, noncomparative; NDD, non–dialysis dependent; OL, open label; PBO, placebo; PC, PBO controlled; PD, peritoneal dialysis; PG, parallel group; R, randomized; rhEPO, recombinant human erythropoietin; SBP, systolic blood pressure; t½, terminal half-life; Tmax, time to Cmax; Vd/F, apparent volume of distribution.