Late-breaking abstracts explore cardiovascular outcomes of patients with anemia in chronic kidney disease (CKD) treated with roxadustat, including associations with achieved hemoglobin levels and risk of Major Adverse Cardiovascular Events (MACE) and MACE+
New analyses evaluate efficacy of roxadustat across the continuum of patients with anemia in CKD – both on dialysis and not on dialysis – including different dialysis modalities, iron repletion status, and comorbidities.
Presentations address safety profile of roxadustat related to neoplasms, hypertension, and ophthalmological effects
Additional presentations explore increased risk of red blood cell transfusion at lower hemoglobin levels and impact of roxadustat on rates of hospitalization due to congestive heart failure
Twenty-eight presentations on roxadustat for the treatment of anemia associated with CKD will further demonstrate the depth and breadth of the roxadustat global Phase 3 development program and build on the known clinical profile of roxadustat in treating a broad spectrum of CKD patients. Another 12 presentations on CKD anemia epidemiology and disease state outline the burden of anemia on CKD patients and their unmet medical need for innovative therapies. In addition, two late-breaking poster presentations will explore associations between cardiovascular safety and hemoglobin levels achieved with roxadustat in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) CKD patients.
“Our roxadustat clinical data at ASN Kidney Week 2020 Reimagined demonstrate consistent efficacy and positive safety results across the continuum of chronic kidney disease patients with anemia, adding to the established body of evidence highlighting roxadustat as a potential foundational treatment for this condition affecting millions of patients,” said
Abstracts assessing the potential clinical profile for use of roxadustat for anemia treatment in CKD patients will include:
- Red Blood Cell (RBC) Transfusion Reduction
Abstracts on the potential of roxadustat to reduce the need for RBC transfusions across the continuum of patients with anemia in CKD include:
Lead Author | Abstract # / Presentation Title | Presentation Details |
Abstract PO0261: Risk of Transfusion in Patients with Non-Dialysis-Dependent CKD Increases with Hemoglobin Levels <10 g/dL vs. ≥10 g/dL: Pooled Results from Roxadustat Phase 3 Studies | Poster Session: Anemia and Iron Management | |
Abstract PO0268: Risk of Transfusion in Patients with Dialysis-Dependent CKD Increases with Hemoglobin Levels <10 g/dL vs. ≥10 g/dL: Pooled Results from Roxadustat Phase 3 Studies | Poster Session: Anemia and Iron Management | |
Abstract PO0264: Roxadustat Treatment Corrects Anemia to Hemoglobin (Hb) Values ≥10 g/dL in the Majority of Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) AstraZeneca-sponsored | Poster Session: Anemia and Iron Management |
- Congestive Heart Failure (CHF) Hospitalization
Abstract comparing the rates of hospitalization due to CHF, a common and serious comorbidity in CKD patients, between roxadustat and comparators:
Lead Author | Abstract # / Presentation Title | Presentation Details |
Poster Session: Hypertension and Vascular Disease: From the Lab to Trials |
- Additional Safety
Abstracts addressing the safety profile of roxadustat include:
Lead Author | Abstract # / Presentation Title | Presentation Details |
Abstract TH-OR04: Roxadustat Is Not Associated with An Increased Risk of Neoplasm in Patients with CKD and Anemia | Poster Session: Breakthroughs in Anemia and Iron Management | |
Abstract PO2114: Roxadustat vs. Placebo or Epoetin-alfa Has No Clinically Meaningful Effect on Blood Pressure in Patients with Anemia of CKD | Poster Session: CVD, BP and Kidney Diseases: Exploring the Link | |
Abstract PO0267: Ophthalmological Effects of Roxadustat in the Treatment of Anemia in Dialysis-Dependent and Non–Dialysis-Dependent CKD Patients: Findings from Two Phase 3 Studies Astellas-sponsored | Poster Session: Anemia and Iron Management |
- Efficacy and Safety
Abstracts building on the known efficacy and safety profile of roxadustat for treatment of anemia across the continuum of CKD severity in patient subgroups with different comorbidities, dialysis status or dialysis modality in both NDD and DD CKD, include:
Lead Author | Abstract # / Presentation Title | Presentation Details |
In Non-Dialysis-Dependent Patients (placebo-controlled studies: OLYMPUS, ANDES, ALPS) | ||
Abstract PO0260: Subgroup Analyses of Efficacy of Roxadustat for Treatment of Anemia in Patients with Non-Dialysis-Dependent CKD | Poster Session: Anemia and Iron Management | |
Abstract PO1032: Efficacy and Safety of Roxadustat in Patients with Non–Dialysis-Dependent CKD, Anemia, and Diabetes Mellitus | Poster Session: Diabetic Kidney Disease: Clinical - 2 | |
Abstract PO2111: Efficacy and Safety of Roxadustat in Patients with Non-Dialysis-Dependent CKD, Anemia, and Heart Failure | Poster Session: CVD, BP and Kidney Diseases: Exploring the Link | |
Roberto Pecoits-Filho, MD | Abstract TH-OR05: Roxadustat Treatment Results in Consistent Improvements in Hemoglobin (Hb) vs. Placebo: An Analysis of Three Multinational Randomized Clinical Trials in Patients with Non-Dialysis-Dependent CKD (NDD-CKD) AstraZeneca-sponsored | Poster Session: Breakthroughs in Anemia and Iron Management |
In Dialysis-Dependent Patients (epoetinalfa controlled studies: ROCKIES, SIERRAS, HIMALAYAS) | ||
Abstract SU-OR24: Efficacy and Safety of Roxadustat in Patients with Dialysis-Dependent CKD and Anemia on Peritoneal Dialysis | Poster Session: Peritoneal Dialysis and Vascular Access: Research Abstracts | |
Abstract PO2112: Efficacy and Safety of Roxadustat in Patients with Dialysis-Dependent CKD, Anemia, and Heart Failure | Poster Session: CVD, BP and Kidney Diseases: Exploring the Link | |
Abstract PO0259: Subgroup Analyses of Efficacy of Roxadustat for Treatment of Anemia in Patients with Incident Dialysis-Dependent CKD | Poster Session: Anemia and Iron Management | |
Abstract PO1031: Efficacy and Safety of Roxadustat in Patients with Dialysis-Dependent CKD, Anemia, and Diabetes Mellitus | Poster Session: Diabetic Kidney Disease: Clinical - 2 | |
Abstract FR-OR25: Efficacy and Safety of Roxadustat in Patients with Dialysis-Dependent CKD and Anemia on Hemodialysis | Poster Session: Hemodialysis and Home Hemodialysis: Research Abstract |
- Efficacy and Safety of Roxadustat Versus Darbepoetin Alfa
Abstract on the primary results of a clinical trial on efficacy and safety of roxadustat in comparison to darbepoetin alfa in non-dialysis dependent patients (DOLOMITES):
Lead Author | Abstract # / Presentation Title | Presentation Details |
Abstract TH-OR02: Roxadustat for the Treatment of Anemia in CKD Patients Not on Dialysis (NDD): A Phase 3, Randomized, Open-label, Active-controlled Study Astellas-sponsored | Poster Session: Breakthroughs in Anemia and Iron Management |
- Inflammation and Iron
Abstracts assessing roxadustat efficacy regardless of inflammation status as well as impact on iron homeostasis:
Lead Author | Abstract # / Presentation Title | Presentation Details |
In Non-Dialysis-Dependent Patients (placebo-controlled studies: OLYMPUS, ANDES, ALPS) | ||
Abstract PO0262: Roxadustat Favorably Modifies Iron Indices in Patients with Non-Dialysis-Dependent CKD-related Anemia | Poster Session: Anemia and Iron Management | |
Abstract PO0263: Roxadustat Increases Hemoglobin in Anemic Non-Dialysis-Dependent (NDD) CKD Patients Independent of Inflammation AstraZeneca-sponsored | Poster Session: Anemia and Iron Management | |
Abstract PO0257: Hemoglobin (Hb) Correction with Roxadustat is Associated with Improved Iron Homeostasis in Patients with Non-Dialysis-Dependent CKD (NDD-CKD) AstraZeneca-sponsored | Poster Session: Anemia and Iron Management | |
In Dialysis-Dependent Patients (epoetinalfa controlled studies: ROCKIES, SIERRAS, HIMALAYAS) | ||
Abstract PO0265: Roxadustat Increases Hemoglobin in Anemic Dialysis-Dependent (DD) CKD Patients Independent of Inflammation AstraZeneca-sponsored | Poster Session: Anemia and Iron Management | |
Abstract TH-OR06: Hemoglobin (Hb) Correction with Roxadustat Is Associated with Improved Iron Homeostasis in Patients with Dialysis-Dependent CKD (DD-CKD) AstraZeneca-sponsored | Poster Session: Breakthroughs in Anemia and Iron Management |
About Anemia Associated with CKD
Chronic kidney disease (CKD) is generally a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure or end stage renal disease, requiring dialysis or kidney transplant. CKD is estimated to occur in approximately 10-12% of adults worldwide and is predicted to become the fifth most common cause of premature death globally by 2040.
Anemia, a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, is a common early complication of CKD, affecting approximately 20% of CKD patients. Anemia in CKD is associated with an increased risk of hospitalization, cardiovascular complications, and death, and can also cause significant fatigue, cognitive dysfunction and reduced quality of life. Blood transfusions are used for treating severe anemia, however, they may reduce a patient’s opportunity for kidney transplant and can increase the risk of infection and/or complications such as heart failure and allergic reactions.
About Roxadustat
Roxadustat is a first-in-class, oral small molecule HIF-PH inhibitor that promotes erythropoiesis through increased endogenous production of erythropoietin; improved iron absorption, transport, and mobilization; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on hemoglobin synthesis and red blood cell production. Roxadustat is approved in
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