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ROXADUSTAT FOR THE TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS NOT ON DIALYSIS: A PHASE 3 RANDOMIZED OPEN-LABEL ACTIVE-CONTROLLED STUDY (DOLOMITES)
JONATHAN BARRATT
; Odjel za kardiovaskularne znanosti, Sveučilište u Leicesteru, Leicester, UK
BRANISLAV ANDRIĆ
; Opća bolnica Kruševac, Kruševac, Srbija
AVTANDIL TATARADZE
; Nacionalni urološki centar, Tbilisi, Gruzija
MICHAEL SCHÖMIG
; Centar za dijalizu u Heilbronnu, Heilbronn, Njemačka
MICHAEL REUSCH
; Astellas Pharma Europe B. V., Leiden, Nizozemska
UDAYA VALLURI
; Astellas Pharma Global Development, Inc., Northbrook, IL, SAD
CHRISTOPHE MARIAT
; Klinički bolnički centar St. Etienne, Odjel za nefrologiju, dijalizu i transplantaciju, St. Etienne, Francuska
Sažetak
Background: Roxadustat, an orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor, is being evaluated for the treatment of anemia of chronic kidney disease (CKD). Methods: This randomized, open-label, active-controlled Phase 3 study compared roxadustat versus darbepoetin alfa (DA) in non-dialysis-dependent (NDD) CKD patients with anemia for ≤104 weeks. Doses were titrated to correct and maintain hemoglobin (Hb) within 10.0-12.0 g/dL. The primary endpoint was Hb response in the full analysis set, defi ned as Hb ≥11.0 g/dL and Hb change from baseline (BL; CFB) ≥1.0 g/dL in patients with BL Hb >8.0 g/dL or CFB ≥2.0 g/dL in patients with BL Hb ≤8.0 g/dL during the fi rst 24 weeks of treatment without rescue therapy (non-inferiority margin, -15%). The key secondary endpoints included change in low-density lipoprotein (LDL), time to fi rst intravenous (IV) iron use, change in mean arterial pressure (MAP), and time to hypertension occurrence. Adverse events were assessed. Results: Of 616 randomized patients (roxadustat, 323; DA, 293), 424 completed treatment (roxadustat, 215; DA, 209). Hb response with roxadustat was non-inferior to DA (roxadustat: 256/286, 89.5% versus DA: 213/273, 78.0%, difference 11.51%, 95% confi dence interval 5.66-17.36%). Roxadustat maintained Hb for up to 2 years. Roxadustat was non-inferior to DA for change in MAP and time to occurrence of hypertension, and superior for change in LDL and time to fi rst IV iron use. Safety profi les were comparable between the groups. Findings suggest that there was no difference between groups regarding the composite endpoints major adverse cardiovascular events (MACEs) and MACE+[MACE: 0.81 (0.52-1.25), p=0.339; MACE+: 0.90 (0.61-1.32), p=0.583]. Conclusions: Roxadustat is a viable option to treat anemia in NDD CKD patients maintaining Hb levels for up to 104 weeks.
Ključne riječi
anemia; chronic kidney disease; erythropoietin; hemoglobin
Hrčak ID:
285258
URI
Datum izdavanja:
7.11.2022.
Posjeta: 667 *