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

Steven Fishbane, Mohamed A. El-Shahawy, Roberto Pecoits-Filho, Bui Pham Van, Mark T. Houser, Lars Frison, Dustin J. Little, Nicolas J. Guzman and Pablo E. Pergola
JASN March 2021, 32 (3) 737-755; DOI: https://doi.org/10.1681/ASN.2020081150
Steven Fishbane
1Department of Medicine, Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, New York
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Mohamed A. El-Shahawy
2Department of Medicine, Keck-University of Southern California School of Medicine, Los Angeles, California
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Roberto Pecoits-Filho
3School of Medicine, Pontifical Catholic University of Parana, Curitiba, Brazil
4Arbor Research Collaborative for Health, Ann Arbor, Michigan
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Bui Pham Van
5Department of Medicine, Pham Ngoc Thach University of Medicine, Ho Chi Minh City, Vietnam
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Mark T. Houser
6Global Medicines Development, Biopharmaceuticals Research & Development, AstraZeneca Gaithersburg, Gaithersburg, Maryland
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Lars Frison
7Biostatistics, Biopharmaceuticals Research & Development, AstraZeneca Gothenburg, Mölndal, Sweden
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Dustin J. Little
6Global Medicines Development, Biopharmaceuticals Research & Development, AstraZeneca Gaithersburg, Gaithersburg, Maryland
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Nicolas J. Guzman
6Global Medicines Development, Biopharmaceuticals Research & Development, AstraZeneca Gaithersburg, Gaithersburg, Maryland
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Pablo E. Pergola
8Renal Associates PA, San Antonio, Texas
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Significance Statement

Anemia is untreated in many patients with non–dialysis-dependent CKD. Barriers to the use of current anemia therapies among such patients include parenteral administration that may require a medical visit, a requirement for iron repletion, and potentially increased risk of cardiovascular events. In a phase 3 placebo-controlled international study, the authors compared roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, with placebo for the treatment of anemia of non–dialysis-dependent CKD. They report that roxadustat was statistically superior to placebo in increasing hemoglobin and reduced the need for red blood cell transfusion. The drug also was generally well tolerated and had an adverse event profile comparable to placebo. These findings indicate that roxadustat may be clinically useful for the oral management of anemia in patients with non–dialysis-dependent CKD.

Abstract

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

  • anemia
  • chronic kidney disease
  • clinical nephrology
  • randomized controlled trials
  • clinical trial
  • Copyright © 2021 by the American Society of Nephrology
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Journal of the American Society of Nephrology: 32 (3)
Journal of the American Society of Nephrology
Vol. 32, Issue 3
March 2021
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Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study
Steven Fishbane, Mohamed A. El-Shahawy, Roberto Pecoits-Filho, Bui Pham Van, Mark T. Houser, Lars Frison, Dustin J. Little, Nicolas J. Guzman, Pablo E. Pergola
JASN Mar 2021, 32 (3) 737-755; DOI: 10.1681/ASN.2020081150

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Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study
Steven Fishbane, Mohamed A. El-Shahawy, Roberto Pecoits-Filho, Bui Pham Van, Mark T. Houser, Lars Frison, Dustin J. Little, Nicolas J. Guzman, Pablo E. Pergola
JASN Mar 2021, 32 (3) 737-755; DOI: 10.1681/ASN.2020081150
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