(PRESS RELEASE) CAMBRIDGE, 5-Jun-2020 — /EuropaWire/ — British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca announced it will present new data across continuum of care from its broad renal portfolio during the 57th virtual congress of the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) between 6 and 9 June 2020.
The 20 abstracts being presented, including four oral presentations, will include data on Lokelma (sodium zirconium cyclosilicate), roxadustat and Farxiga (dapagliflozin) across different stages of chronic kidney disease (CKD) and AstraZeneca’s ongoing commitment to exploring treatment options across the full continuum of renal care.
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, said: “More than 700 million people around the world are affected by chronic kidney disease, a progressive condition, for which no cure currently exists. Our data at ERA-EDTA demonstrate advances across all stages of the disease, from prevention and protection, to slowing progression and managing serious complications.”
Advancing treatment of hyperkalaemia for CKD patients, including those on dialysis
AstraZeneca will present a series of sub-analyses from the Lokelma Phase IIIb DIALIZE trial reinforcing the effectiveness of this medicine to manage hyperkalaemia in patients with CKD on haemodialysis, irrespective of factors such as sex, country, age, weight or disease severity.1,2
Hyperkalaemia is a common complication in patients with CKD, and can result in serious arrhythmias, sudden cardiac arrest, paralysis and weakness, and even death.3,4 Beyond DIALIZE, real-world evidence will be presented showing that the number of cardiovascular (CV) or renal comorbidities increases the risk of hyperkalaemia in patients with CKD, highlighting the need for effective prevention and treatment.5
Evaluating efficacy and safety of treatment for anaemia CKD patients
Results will be presented from a Phase III trial assessing roxadustat versus darbepoetin alfa for the treatment of anaemia in CKD patients not on dialysis. A prespecified analysis from an additional Phase III trial will also be presented, assessing the ophthalmological/retinal effects of roxadustat in the treatment of anaemia in dialysis-dependent CKD patients compared to darbepoetin alfa.6
AstraZeneca and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in the US, China and other markets in the Americas and in Australia/New Zealand, as well as Southeast Asia. Astellas and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa. Astellas sponsored both trials and will be presenting these data.
Showing the need for improved treatments for CKD patients with real-world evidence
AstraZeneca continues to investigate opportunities to enable earlier intervention in CKD, since globally the disease is underdiagnosed, and patients may not realise they have the disease until it has advanced.7,8
At the congress, new analyses of real-world data on type-2 diabetic and non-diabetic patients with CKD will be presented which demonstrate a need for additional treatment options to improve adverse renal, CV and mortality outcomes and reduce the burden on patients and healthcare systems.9,10
Furthermore, a real-world analysis of the DISCOVER-CKD trial will be shared showing a high prevalence of type-2 diabetes and high blood pressure in patients with CKD, demonstrating the high comorbidity burden in this group for whom new therapies may be beneficial.11
Key AstraZeneca presentations and other notable abstracts during the 57th ERA-EDTA Congress include:
|Sodium Zirconium Cyclosilicate Corrects Hyperkalaemia Within 72 hours Among Outpatients With Severe Hyperkalaemia (Baseline Serum Potassium ≥6 mmol/L) Regardless of Renal Function Level or RAASi Use: Post Hoc Subgroup Analysis of a Phase 3 Trial
|Subgroup Efficacy Analysis of Sodium Zirconium Cyclosilicate (SZC) in Hyperkalaemic Haemodialysis Patients in the DIALIZE Study
|A Randomized, Double-blind, Placebo-Controlled Multicenter Study of the Effects of 12 Weeks of Sodium Zirconium Cyclosilicate (ZS-9) on Albuminuria (UACR) in Patients with Type 2 Diabetes and Hyperkalemia
|Effectiveness of Sodium Zirconium Cyclosilicate (SZC) in Haemodialysis Patients with Severe Hyperkalaemia in the DIALIZE Study
|KEEP ON (KEEping RAAS inhibition treatment with optimal Potassium cONtrol). Design of a Clinical Trial of Using Sodium Zirconium Cyclosilicate for keeping RAAS Inhibition and/or MRAs in Patients with Chronic Kidney Disease and Congestive Heart Failure History
|Sodium Zirconium Cyclosilicate Increases Serum Bicarbonate Concentrations Among Patients with Hyperkalaemia: Results from Three Randomized, Multi-Dose, Placebo-Controlled Trials
|Healthy K-Rich Diet in Chronic Kidney Disease (CKD) Patients Using Sodium Zirconium Cyclosilicate (SZC) to Control Hyperkalemia: A Feasibility Study (HELPFUL)
|Ophthalmological Effects of Roxadustat in the Treatment of Anaemia in Chronic Kidney Disease Patients on Dialysis: Sub-Analysis of a Phase 3, Randomised, Double-Blind, Active-Comparator Conversion Study
|Roxadustat for the Treatment of Anaemia in Chronic Kidney Disease Patients not on Dialysis: A Phase 3, Randomised, Open-Label, Active-Controlled Study
|Groenendaal-van de Meent, D.
|Effect of Severe Renal Impairment or End-Stage Renal Disease on the Pharmacokinetics and Pharmacodynamics of Roxadustat, an Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor
|Characterization of a DAPA-CKD-Like Population Using a Contemporary US Healthcare System: Cohort Characteristics and Clinical Outcomes
|Healthcare Resource Utilization and Costs in a DAPA-CKD-Like Population Using a Contemporary US Healthcare Cohort
|Cardiovascular, Renal & Metabolism (CVRM): CKD
|A Real-world Longitudinal Analysis of Anemia Treatment Prescriptions in Non-Dialysis-Dependent Chronic Kidney Disease Patients, a CKDopps Study
|Estimating the Burden of Chronic Kidney Disease (CKD) in the UK: Comparison of Two Health Economic Policy Analysis Methods
|Pre-Dialysis Haemoglobin Target Attainment and Post-Dialysis Outcomes in Persons with Renal Anaemia: A Nationwide Study
|Garcia Sanchez, J.J.
|Clinical Characteristics and eGFR and UACR Distribution According to the 2012 KDIGO CKD Classification: A Report from the US DISCOVER CKD Cohort
|A Qualitative Study of Patients’ Preference for the Treatment of Anaemia Associated with Chronic Kidney Disease
|Complement factor Bb and Factor C4d in IgA Nephritis and IgA Vasculitis
|The Association Between Hyperkalaemia Risk and Cardiovascular and Renal Comorbidities in a Large Real-world Cohort of CKD Patients
|Patterns of Hyperkalaemia Recurrence Among Chronic Kidney Disease Patients in UK Clinical Practice
All ERA-EDTA 2020 Virtual Congress abstracts will be made available online on Friday 5 June 2020 in an abstract supplement to be published with the June issue of the Nephrology Dialysis Transplantation Journal
AstraZeneca in CVRM
Cardiovascular, Renal and Metabolism (CVRM) together forms one of AstraZeneca’s three therapy areas and is a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling comorbidities. The Company’s ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
- McCafferty K et al. Subgroup Efficacy Analysis of Sodium Zirconium Cyclosilicate (SZC) in Hyperkalaemic Haemodialysis Patients in the DIALIZE Study. presented at: 57th ERA-EDTA Virtual Congress, 2020 June 7-9.
- Ford M et al. Effectiveness of Sodium Zirconium Cyclosilicate (SZC) in Haemodialysis Patients with Severe Hyperkalaemia in the DIALIZE Study. presented at: 57th ERA-EDTA Virtual Congress, 2020 June 7-9.
- Bansal S, Pergola PE. Current Management of Hyperkalemia in Patients on Dialysis. Kidney Int Rep 2020.
- American Heart Association. Part 10.1: Life-Threatening Electrolyte Abnormalities. Circulation 2005; 112(24_suppl):IV-121-IV-125.
- Hoskin L et al. The association between hyperkalaemia risk and cardiovascular and renal comorbidities in a large real-world cohort of CKD patients. presented at: 57th ERA-EDTA Virtual Congress, 2020 June 7-9.
- Sepah Y et al. Ophthalmological Effects of Roxadustat in the Treatment of Anaemia in Chronic Kidney Disease Patients on Dialysis: Sub-Analysis of a Phase 3, Randomised, Double-Blind, Active-Comparator Conversion Study. presented at: 57th ERA-EDTA Virtual Congress, 2020 June 7-9.
- National Kidney Foundation. Kidney Disease: The Basics [cited 26.05.20]. Available from: URL: https://www.kidney. org/news/newsroom/factsheets/KidneyDiseaseBasics.
- National Kidney Disease Education Program. Chronic Kidney Disease: What Is Chronic Kidney Disease? [cited 26.05.20]. Available from: URL: https://www.niddk.nih.gov/health-information/kidney-disease/chronic-kidney-disease-ckd/what-is-chronic-kidney-disease.
- Olufade T et al. Characterization of a DAPA-CKD-like population using a contemporary US Healthcare System: Cohort characteristics and clinical outcomes. presented at: 57th ERA-EDTA Virtual Congress, 2020 June 7-9.
- Olufade T et al. Healthcare resource utilization and costs in a DAPA-CKD-like population using a contemporary US healthcare cohort. presented at: 57th ERA-EDTA Virtual Congress, 2020 June 7-9.
- Garcia Sanchez JJ et al. Clinical characteristics and eGFR and UACR distribution according to the 2012 KDIGO CKD classification: A Report from the US DISCOVER CKD Cohort. presented at: 57th ERA-EDTA Virtual Congress, 2020 June 7-9.