Table 1.

Summary of recently published and ongoing trials with the new class of hypoxia-inducible factor prolyl hydroxylase agents in CKD, including the patient-reported outcomes captured in the studies

Drug and NCT ReferenceStudy PopulationNo.Active Comparator(s) DrugPrimary OutcomeDurationStart Date; Estimated Completion DatePRO dataSF-36FACT-AnEQ-5D 5LEQ-VASWPAI:ANSPGI-SPGI-CCKD-AQ
Roxadustat
 02021318 (Dolomites)ND-CKD570Darbepoetin alfaHb response24 wk up to 108 wk03/2014–04/2020XXXXXX
 01887600 (ALPS)ND-CKD597PlaceboHb change from baseline52 wk up to 108 wk09/2013–11/2017XXXXXX
 02988973ND-CKD325Darbepoetin alfaHb change from baseline24 wk up to 52 wk01/2017–11/2018XXXXX
 02964936ND-CKD100N/AHb response24 wk01/2017–05/2018XXX
 02174627 (OLYMPUS)ND-CKD2700PlaceboMACEEvent driven06/2014–03/2018XXX
 02652819ND-CKD154PlaceboHb change from baseline53 wk12/2015–06/2017XX
 01750190 (ANDES)ND-CKD922PlaceboHb response52 wk11/2012–03/2018
 01630889 (phase 2/3)ND-CKD and DD-CKD50N/AMaintenance HbUp to 5 yr05/2012–12/2018X
Vadadustat
 2648347 (PRO2TECT-CORRECTION)ND-CKD1000Darbepoetin alfaHb change from baselineEvent driven12/2015–11/2018X
 2680574 (PRO2TECT-CONVERSION)ND-CKD2100Darbepoetin alfaHb change from baselineEvent driven02/2016–11/2018
Dapradustat
 02791763ND-CKD/PD320Epoetin beta pegolMean Hb level52 wk6/2016–6/2018
 03409107 (ASCEND-NHQ)ND-CKD600PlaceboHb change from baseline28 wk03/2018–10/2020XXXXXXXX
 02876835 (ASCEND-ND)ND-CKD4500Darbepoetin alfaHb change from baselineEvent driven09/2016–01/2021XXXXXXXX
Molidustat
 03350321 (MIYABI ND-C)ND-CKD166Darbepoetin alfaMean Hb level52 wk12/2017–05/2019
 03350347 (MIYABI ND-M)ND-CKD162Darbepoetin alfaMean Hb level52 wk12/2017–11/2019
  • NCT, National Clinical Trial number; PRO, patient-reported outcomes; SF-36, Short-Form 36; functional assessment of cancer therapy-anemia; EQ-5D-5L, EuroQol 5-dimensions 5-levels; EQ-VAS, EuroQol Visual Scale; WPAI:AN, work productivity and impairment questionnaire anemia symptoms; PGI-S, patient global impression of severity; PGI-C, patient global impression of change; CKD-AQ, CKD anemia questionnaire; ND-CKD, nondialysis CKD; Hb, hemoglobin; X, patient-reported outcomes captured in the studies; N/A, not applicable; MACE, major adverse cardiovascular events; DD-CKD, dialysis-dependent CKD; PD, peritoneal dialysis; ASCEND-NHQ, Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life; ASCEND-ND, Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis; MIYABI ND-C, A Study of Molidustat for Correction of Renal Anemia in Non-Dialysis Subjects; MIYABI ND-M, A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-Dialysis Subjects.