Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study.

Autor:	Fishbane S; Department of Medicine, Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, New York., El-Shahawy MA; Department of Medicine, Keck-University of Southern California School of Medicine, Los Angeles, California., Pecoits-Filho R; School of Medicine, Pontifical Catholic University of Parana, Curitiba, Brazil.; Arbor Research Collaborative for Health, Ann Arbor, Michigan., Van BP; Department of Medicine, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, Vietnam., Houser MT; Global Medicines Development, Biopharmaceuticals Research & Development, AstraZeneca Gaithersburg, Gaithersburg, Maryland., Frison L; Biostatistics, Biopharmaceuticals Research & Development, AstraZeneca Gothenburg, Mölndal, Sweden., Little DJ; Global Medicines Development, Biopharmaceuticals Research & Development, AstraZeneca Gaithersburg, Gaithersburg, Maryland., Guzman NJ; Global Medicines Development, Biopharmaceuticals Research & Development, AstraZeneca Gaithersburg, Gaithersburg, Maryland., Pergola PE; Renal Associates PA, San Antonio, Texas.
Jazyk:	angličtina
Zdroj:	Journal of the American Society of Nephrology : JASN [J Am Soc Nephrol] 2021 Mar; Vol. 32 (3), pp. 737-755. Date of Electronic Publication: 2021 Feb 10.
DOI:	10.1681/ASN.2020081150
Abstrakt:	Background: Current anemia therapies for patients with non-dialysis-dependent CKD may require injection and medical visits. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, stimulates erythropoiesis and improves iron homeostasis. Methods: In this double-blind phase 3 study, we randomized patients with non-dialysis-dependent CKD stages 3-5 and hemoglobin <10.0 g/dl (1:1) to thrice-weekly 70-mg oral roxadustat or placebo. Doses were titrated throughout the study based on hemoglobin levels. The primary efficacy end point was mean change from baseline in hemoglobin averaged over weeks 28-52 versus placebo, irrespective of rescue therapy use. We assessed patients for adverse events. Results: The study included 2781 patients, 1393 who received roxadustat and 1388 who received placebo. Mean baseline hemoglobin was 9.1 g/dl for both groups. The mean change in hemoglobin from baseline was 1.75 g/dl (95% confidence interval [95% CI], 1.68 to 1.81) with roxadustat versus 0.40 g/dl (95% CI, 0.33 to 0.47) with placebo, ( P <0.001). Among 411 patients with baseline elevated high-sensitivity C-reactive protein, mean change in hemoglobin from baseline was 1.75 g/dl (95% CI, 1.58 to 1.92) with roxadustat versus 0.62 g/dl (95% CI, 0.44 to 0.80) with placebo, ( P <0.001). Roxadustat reduced the risk of red blood cell transfusion by 63% (hazard ratio, 0.37; 95% CI, 0.30 to 0.44). The most common adverse events with roxadustat and placebo, respectively, were ESKD (21.0% versus 20.5%), urinary tract infection (12.8% versus 8.0%), pneumonia (11.9% versus 9.4%), and hypertension (11.5% versus 9.1%). Conclusions: Roxadustat effectively increased hemoglobin in patients with non-dialysis-dependent CKD and reduced the need for red blood cell transfusion, with an adverse event profile comparable to that of placebo. Clinical Trial Registry Name and Registration Number: Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With CKD, Not on Dialysis, NCT02174627. (Copyright © 2021 by the American Society of Nephrology.)
Databáze:	MEDLINE
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