AstraZeneca presents more than 80 abstracts at ASN Kidney Week 2020 Reimagined

22 – 25 October 2020

We are presenting 84 abstracts, including 12 oral presentations and three late-breaking abstracts across our renal portfolio, which includes roxadustat, Farxiga (dapagliflozin) and Lokelma (sodium zirconium cyclosilicate).
 

  • More than 40 abstracts will be presented on roxadustat, an oral hypoxia-inducible-factor prolyl hydroxylase inhibitor (HIF-PHI), which will provide new insights on potential treatment in anaemia of chronic kidney disease (CKD)

  • New late-breaking subgroup data from the DAPA-CKD Phase III trial evaluating the potential benefit of Farxiga (dapagliflozin) in patients with CKD irrespective of the underlying cause

  • New sub-analyses of the DIALIZE Phase IIIb trial and real-world evidence in patients living with CKD and hyperkalaemia evaluate the potential of Lokelma (sodium zirconium cyclosilicate) as an option for hyperkalaemia management.

At AstraZeneca, we are committed to advancing science and bringing life-changing therapies to those who need them most. Our presence at the ASN Kidney Week 2020 Reimagined will help advance our ambition to create a coordinated pathway for renal patients.






Our Abstracts



Roxadustat

Clinical trial data investigates roxadustat* as a potential treatment for anaemia in both dialysis-dependent (DD) and non dialysis-dependent (NDD) patients with CKD. Highlights include late-breaking presentations investigating the association between haemoglobin concentrations and CV outcomes; data evaluating whether roxadustat can reduce the risk of hospitalisation for heart failure and the risk of red blood cell transfusions in both DD-CKD and NDD-CKD patients; an exploration of roxadustat’s effect on haemoglobin levels in patients with NDD-CKD; new data on DD-CKD patient subgroups, including those who are receiving peritoneal dialysis and are new to dialysis.


Farxiga (dapagliflozin)

New late-breaking sub-group data from the DAPA-CKD Phase III trial evaluating the potential benefit of dapagliflozin in patients with CKD irrespective of the underlying cause. An encore presentation of data from the DECLARE-TIMI 58 trial evaluating the potential effect of dapagliflozin on the risk for fast decline in eGFR, a marker of renal function, in patients with type-2 diabetes (T2D) and established or increased risk for CV disease will be presented. Additionally, a new sub-analysis of the DAPA-HF trial will investigate whether dapagliflozin reduces the risk of hyperkalaemia in patients with heart failure with reduced ejection fraction.

Lokelma (sodium zirconium cyclosilicate)

New sub-analyses from the DIALIZE trial and real-world evidence in patients living with CKD and hyperkalaemia evaluate the potential of sodium zirconium cyclosilicate as an option for hyperkalaemia management. Hyperkalaemia is a common complication in patients with CKD, and if not managed effectively, complications like hyperkalaemia can impact ongoing treatment approaches, leading to life-saving treatments being reduced or discontinued.


Real-world evidence

Real-world evidence from the novel DISCOVER CKD study, reveals practice patterns and explores the burden of CKD with the aim of providing a better understanding of the unique challenges and experiences of CKD patients and identify actionable gaps in the treatment and management of patients with CKD.



CKD Personal Impact Index

AstraZeneca will also launch the CKD Personal Impact Index, which aims to better understand and measure the impact of the disease and its complications on the day-to-day lives of individuals and their families beyond the standard Quality of Life analyses.



Robert Provenzano

Dr Robert Provenzano Associate Clinical Professor of Medicine

Robert Provenzano is an Associate Clinical Professor of Medicine at Wayne State University School of Medicine in Detroit, Michigan. He has served previously as the Chief of the Division of Nephrology, Hypertension & Transplantation, Director of Nephrology Research, and Director of Acute Dialysis Services at St John Hospital & Medical Center in Detroit, MI., Chief Operating Officer of St Clair Specialty Physicians in Detroit, and the Vice President of Medical Affairs for DaVita Inc. Dr. Provenzano has recently overseen all of the owned & managed practice for DaVita as its CMO for Nephrology Practice Solutions (NPS). Currently he has focused, in a consultant role, on anemia management for CKD and ESRD patients for several Pharmaceutical organizations.


Hiddo Lambers Heerspink

Hiddo Lambers Heerspink University Medical Center Groningen

Professor Heerspink is co-chair of the DAPA-CKD Phase III trial and its executive committee. He is a Clinical Pharmacologist at the University Medical Center Groningen. His main research interests include optimising treatment strategies and finding new therapeutic approaches to halt the progression of renal and cardiovascular disease.






ASN Kidney Week 2020 Reimagined

Register now to be able to follow the live experience.

Associations between Achieved Hemoglobin and Cardiovascular Outcomes in the Pooled Phase 3 Trials of Roxadustat in Dialysis-dependent Patients with Anemia of Chronic Kidney Disease. #PO2626

Associations between Achieved Hemoglobin and Cardiovascular Outcomes in the Pooled Phase 3 Trials of Roxadustat in Non-Dialysis-dependent Patients with Anemia of Chronic Kidney Disease. #PO2625

The Relationships Between Chronic Kidney Disease Duration, Serum Potassium Level and Adverse Outcomes. #PO1450

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). #PO0264

Treatment pathways of non-dialysis dependent CKD patients with anemia: A report from the DISCOVER CKD retrospective cohort. #PO0287

Effects of dapagliflozin on kidney function, cardiovascular events and all-cause mortality according to cause of kidney disease in the DAPA-CKD trial. #FR-OR58

Pooled Analyses of the Phase 3 Roxadustat Studies: Congestive Heart Failure Hospitalization Rates in Dialysis and Non-Dialysis Patients with Anemia treated with Roxadustat versus Comparators. #SA-OR39










Full Abstract List

All ASN Kidney Week 2020 Reimagined abstracts are available via the Congress Platform for registered participants.

Roxadustat

  • Roxadustat Treatment of Anemia in Non-Dialysis-Dependent Chronic Kidney Disease is Not Influenced by Iron Status – Provenzano, R. (Oral: October 22, 5:36–5:48 PM EDT) 
  • Hemoglobin (Hb) Correction with Roxadustat Is Associated with Improved Iron Homeostasis in Patients with Dialysis-Dependent Chronic Kidney Disease (DD-CKD) – Pergola, P.E. (Oral: October 22, 6:00–6:12 PM EDT) 
  • Roxadustat Treatment Results in Consistent Improvements in Hemoglobin (Hb) Versus Placebo: An Analysis of 3 Multinational RCTs in Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) – Pecoits-Filho, R. (Oral: October 22, 5:24–5:36 PM EDT) 
  • Pooled Analyses of the Phase 3 Roxadustat Studies: Congestive Heart Failure Hospitalization Rates in Dialysis and Non-Dialysis Patients with Anemia treated with Roxadustat versus Comparators – Provenzano, R. (Oral: October 24, 6:36–6:48 PM EDT) 
  • Efficacy and Safety of Roxadustat in Patients with Dialysis-dependent Chronic Kidney Disease and Anemia on Hemodialysis – Provenzano, R. (Oral: October 23, 5:48–6:00 PM EDT) 
  • Efficacy and Safety of Roxadustat in Patients with Dialysis-dependent Chronic Kidney Disease and Anemia on Peritoneal Dialysis – Chan, T.M. (Oral: October 25, 5:36–5:48 PM EDT) 
  • Roxadustat for the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients Not on Dialysis (NDD): A Phase 3, Randomized, Open-Label, Active-Controlled Study – Barratt, J. (Oral: October 22, 5:12–5:24 PM EDT) 
  • Adverse Event Rates are Higher Post-transfusion vs. Overall Follow-up and Independent of Background Anemia Treatment in Patients with Chronic Kidney Disease – Provenzano, R. (Oral: October 22, 6:12–6:24 PM EDT) 
  • Roxadustat Is Not Associated with An Increased Risk of Neoplasm in Patients with Chronic Kidney Disease and Anemia – Coyne, D.W. (Oral: October 22, 5:48–6:00 PM EDT) 
  • Associations between Achieved Hemoglobin and Cardiovascular Outcomes in the Pooled Phase 3 Roxadustat Studies of Non-dialysis-dependent Patients with Anemia of Chronic Kidney Disease – Provenzano, R. (Late-breaker session: October 23, 10:30-12:30 EDT ePoster # PO2625)
  • Associations between Achieved Hemoglobin and Cardiovascular Outcomes in the Pooled Phase 3 Trials of Roxadustat in Dialysis-dependent Patients with Anemia of Chronic Kidney Disease – Provenzano, R. (Late-breaker session: October 23, 10:30-12:30 EDT ePoster # PO
  • Roxadustat vs. Placebo or Epoetin Alfa Has No Clinically Meaningful Effect on Blood Pressure in Patients with Anemia of Chronic Kidney Disease –Chan, T.M. (ePoster # P02114) 
  • Impact of Renal Impairment and Dialysis on the Pharmacokinetics and Pharmacodynamics of Roxadustat – Meent, D. (ePoster # PO2369) 
  • Roxadustat Lowers Risk of RBC Transfusion in Patients with Anemia of CKD – Fishbane, S. (ePoster # PO0256) 
  • Hemoglobin (Hb) Correction with Roxadustat Is Associated with Improved Iron Homeostasis in Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) – Fishbane, S. (ePoster # PO0257) 
  • Roxadustat Increases Hemoglobin in Anemic Dialysis-Dependent (DD) Chronic Kidney Disease (CKD) Patients Independent of Inflammation – El-Shahawy, M. (ePoster # PO0265) 
  • 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) – Rastogi, A. (ePoster # PO0264) 
  • Roxadustat Increases Hemoglobin in Anemic Non-Dialysis-Dependent (NDD) Chronic Kidney Disease (CKD) Patients Independent of Inflammation – Pollock, C.A. (ePoster # PO0263) 
  • Roxadustat Favorably Modifies Iron Indices in Patients with Non–dialysis-dependent Chronic Kidney Disease-related Anemia – Coyne, D.W. (ePoster # PO0262) 
  • Efficacy and Safety of Roxadustat in Patients with Dialysis-dependent Chronic Kidney Disease, Anemia, and Diabetes Mellitus – Chan, T.M. (ePoster # PO1031) 
  • Subgroup Analyses of Efficacy of Roxadustat for Treatment of Anemia in Patients with Non-Dialysis-Dependent Chronic Kidney Disease – Coyne, D.W. (ePoster # PO0260) 
  • Efficacy and Safety of Roxadustat in Patients with Non–dialysis-dependent Chronic Kidney Disease, Anemia, and Diabetes Mellitus – Roger, S.D. (ePoster # PO1032) 
  • Risk of Transfusion in Patients with Dialysis-dependent Chronic Kidney Disease Increases with Hemoglobin Levels <10 g/dL vs. ≥10 g/dL: Pooled Results from Roxadustat Phase 3 Studies – Provenzano, R. (ePoster # PO0268) 
  • A Phase 3, Multicenter, Randomized, Open-label, Active Comparator Conversion Study of Roxadustat in Non–Dialysis-Dependent (NDD) Patients with Anemia in Chronic Kidney Disease (CKD) – Azikawa, T. (ePoster # PO0269) 
  • Ophthalmological Effects of Roxadustat in the Treatment of Anemia in Dialysis-Dependent and Non–Dialysis-Dependent Chronic Kidney Disease Patients: Findings From Two Phase 3 Studies – Nguyen, Q.T. (ePoster # PO0267) 
  • A Marginal Structural Model to Estimate Causal Effect of Time-Dependent Anemia Status on Renal and CV Outcomes among Community-Dwelling Japanese Subjects at Beginning of Impaired Renal Function – Onazowa, S. (ePoster # PO2070) 
  • Cost and Healthcare Resource Use in Patients with Anemia in CKD Using Linked US Claims and Electronic Health Records – Wittbrodt, E.T. (ePoster # PO0274) 
  • Patient Preferences Study for Treatment of Anemia in Chronic Kidney Disease (CKD) Patients Not on Dialysis (NDD) – Alexandre, A.F. (ePoster # PO0289) 
  • Rates of Clinical Events in Patients with Chronic Kidney Disease: A UK Population-Based Cohort Study – Sultan, A.A. (ePoster # PO0522) 
  • Understanding Treatment of Severe Anemia due to Chronic Kidney Disease: A Descriptive Study in Non-Dialysis MAPD Patients – Davis, J. (ePoster # PO0273) 
  • Efficacy and Safety of Roxadustat in Patients with Dialysis-dependent Chronic Kidney Disease, Anemia, and Heart Failure – Coyne, D.W. (ePoster # PO2112) 
  • Prevalence of Severe Anemia and Transfusion Risk in Medicare and Non-Medicare Populations with CKD Stages 3 and 4 – Davis, J. (ePoster # PO0276) 
  • Clinical Outcomes in Patients with Anemia in Chronic Kidney Disease Using Linked US Claims and Electronic Health Records – Wittbrodt, E.T. (ePoster # PO0278) 
  • Efficacy and Safety of Roxadustat in Patients with Non–Dialysis-Dependent Chronic Kidney Disease, Anemia, and Heart Failure – Roger, S.D. (ePoster # PO2111) 
  • Risk of Transfusion in Patients with Non–dialysis-dependent Chronic Kidney Disease Increases with Hemoglobin Levels <10 g/dL vs. ≥10 g/dL: Pooled Results from Roxadustat Phase 3 Studies – Coyne, D.W. (ePoster # PO0261) 
  • Health-Related Quality of Life in Roxadustat-treated Patients with Anemia and Non–dialysis-dependent Chronic Kidney Disease – Coyne, D.W. (ePoster # PO0258) 
  • Roxadustat Lowers Low-density Lipoprotein Cholesterol in Patients with Anemia of Chronic Kidney Disease –Roger, S.D. (ePoster # PO2113) 
  • Prevalence and Severity of Anemia Between Non-Dialysis and Dialysis Outpatients Referred to Nephrology Consultation: Epidemiologic Data from 1,568 Mexican Patients at a National Reference Hospital – Perez-Navarro, L.M. (ePoster # PO0294) 
  • Subgroup Analyses of Efficacy of Roxadustat for Treatment of Anemia in Patients with Incident–Dialysis-dependent Chronic Kidney Disease – Provenzano, R. (ePoster # PO0260) 


Farxiga (dapagliflozin)

  • Dapagliflozin Reduces the Risk of Hyperkalemia in Patients with Heart Failure and Reduced Ejection Fraction: A Secondary Analysis DAPA-HF – Kristensen, J.H. (Oral: October 23, 5:00-7:00 PM EDT) 
  • Effects of Dapagliflozin on Kidney Function, Cardiovascular Events and All-Cause Mortality According to Cause of Kidney Disease in the DAPA-CKD Trial [Abstract embargoed] – Wheeler, D.C. (Oral: October 23, 12:15 PM-12:30 PM EDT) 
  • Effect of Dapagliflozin on Risk for Fast Decline in eGFR: Analysis from DECLARE-TIMI 58 Trial – Mozenson, O. (ePoster # PO1010) 
  • Effects of the SGLT2 Inhibitor Dapagliflozin on Proteinuria in Non-Diabetic Patients with Chronic Kidney Disease (DIAMOND): A Randomized Double-Blind Cross-Over Trial – Heerspink, H.J.L. (ePoster # PO0588) 
  • The Impact of Decline in Renal Function on the Clinical and Economic Burden of Chronic Kidney Disease: An Application of the DAPA-CKD Cost-Effectiveness Model – McEwan, P. (ePoster # PO0589) 
  • Lower Cardiorenal Risk with SGLT2i versus DPP4i in T2D Patients without Established Cardiovascular- and Renal Diseases: A Large Multinational Observational Study – Birkeland, K.I. (ePoster # PO0954) 
  • Renal Outcomes and All-Cause Death Associated with SGLT-2 Inhibitor Versus Other Glucose-Lowering Drugs (CVD-REAL 3 Korea) – Koh, E.S. (ePoster # PO1012) 
  • Treatment for Chronic Kidney Disease: A Systematic Literature Review and Population Comparison – Garcia-Sanchez, J.J. (ePoster # PO0570) 
  • The DAPA-CKD-Like Population in a Contemporary US Healthcare System: Cohort Characteristics and Clinical Outcomes– Olufade, T. (ePoster # PO0422) 
  • Healthcare Resource Utilization and Costs in a DAPA-CKD-Like Population Using a Contemporary US Healthcare Cohort – Olufade, T. (ePoster # PO0499) 


Lokelma (sodium zirconium cyclosilicate)

  • A Real-World Longitudinal Analysis of Anemia Treatment Prescriptions in Non-Dialysis-Dependent Chronic Kidney Disease Patients, a CKDopps Study – Lopes M. (Oral: October 22, 6:48–7:00 PM EDT) 
  • Disease Course of Hyperkalemia in Patients on Hemodialysis – Spinowitz, B. (ePoster # PO1165) 
  • Risk of Hypokalemia in Hyperkalemic Hemodialysis Patients – Fishbane, S. (ePoster # PO1051) 
  • The Relationship Between Comorbidities and Hyperkalaemia in Patients with Chronic Kidney Disease – Tafesse, E. (ePoster # PO1448) 
  • The Relationships Between Chronic Kidney Disease Duration, Serum Potassium Level and Adverse Outcomes – Tafesse, E. (ePoster # PO1450) 
  • Patient Palatability and Preference Study of 3 Potassium Binders in Patients with Chronic Kidney Disease and Hyperkalemia: Rationale and Design of the APPETIZE Study – James, G. (ePoster # PO1456) 
  • Prevalence of Diabetes, Hypertension, Anemia and Hyperkalemia as Frequent Comorbidities in Patients with Chronic Kidney Disease Regardless of Their KDIGO Staging – Perez-Navarro, L.M. (ePoster # PO0294) 
  • Patient and Clinician Preferences for Hyperkalemia Treatment: A Qualitative Study – Israni, R. (ePoster # PO1455) 
  • Time to Hyperkalemia Recurrence in One Year among 103,155 US Veterans – Hsuing, J.T. (ePoster # PO2054) 
  • Prevalence and Severity of Hyperkalemia in Patients Referred to Nephrology Consultation: Epidemiologic Data from 1,106 Mexican Patients at a National Reference Hospital – Perez-Navarro, L.M. (ePoster # PO0479) 
  • Machine Learning Models for Risk Prediction of Adverse Events in Hyperkalemic Patients – Kanda, E. (ePoster # PO1453) 
  • Post-Discharge Outcomes Among Hyperkalemic Patients Treated with and without SPS in the Inpatient Setting – Davis, J. (ePoster # PO1445) 
  • Hyperkalaemia Risk and Mortality in Patients with Diabetes – Tafesse, E. (ePoster # PO0968) 


DISCOVER CKD

  • Clinical Characteristics and eGFR and UACR Distribution According to the 2012 KDIGO CKD Classification: A Report from the DISCOVER CKD International Retrospective Cohort – Garcia-Sanchez, J.J. (ePoster # PO0421) 
  • Treatment Pathways of CKD Patients Defined by the 2012 KDIGO CKD Classification: A Report from the DISCOVER CKD Retrospective Cohort – Garcia-Sanchez, J.J. (ePoster # PO0502) 
  • Defining the Excess Risk of Adverse Kidney Outcomes in CKD Patients with Type 2 Diabetes in DISCOVER CKD Cohort – Sultan, A.A. (ePoster # PO0436 
  • Characteristics of Chronic Kidney Disease Patients with Hyperkalemia: A Report from the DISCOVER CKD Retrospective Cohort – James, G. (ePoster # PO1461) 
  • Treatment Pathways of Non-Dialysis Dependent CKD Patients with Anemia: A Report from the DISCOVER CKD Retrospective Cohort – Wittbrodt, E. (ePoster # PO0287) 
  • Healthcare Resource Utilisation and Costs of Chronic Kidney Disease According to the 2012 KDIGO CKD Classification: A Report from the DISCOVER CKD Retrospective Cohort – Garcia-Sanchez, J.J. (ePoster # PO0498) 
  • Treatment Pathways of Patients with Chronic Kidney Disease: A Report from the DISCOVER CKD Retrospective Cohort – James, G. (ePoster # PO0503) 
  • Baseline Characteristics of Non-Dialysis CKD Patients with and without Anemia: A Report from the Retrospective Cohort from DISCOVER CKD – Wittbrodt, E. (ePoster # PO0486) 


Brilinta
 (ticagrelor)

  • During P2Y12 Antiplatelet Therapy, Treatment of Anemia Was More Frequent among Peripheral Artery Disease Patients with Lower eGFR: The EUCLID Trial – Hsia, J. (ePoster # PO0543)


Cotadutide

  • Efficacy and Safety of Cotadutide, a Dual GLP-1 and Glucagon Receptor Agonist, for Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease – Parker, V.E.R. (ePoster # PO1018)


General CKD

  • Development of a Global Chronic Kidney Disease-Personal Impact Index (CKD-PII) Assessing the Reality of Living with CKD – James, M. (ePoster # PO0577) 
  • Estimating the Future Burden of Chronic Kidney Disease in the UK and Globally – L. Retat (ePoster # PO0524) 


Early CVRM

  • Targeting avb8 Integrin Improves Renal Function Through Local Inhibition of TGFb Activation – Marin, E.L. (ePoster # PO0894) 
  • Integrin aVb8/TGFb Activation in Kidney Is Associated with Renal Function Deterioration and Can Be Monitored in Urine – Wang, X. (ePoster # PO0909) 
  • Using Clustering to Facilitate Gene-Based Rare-Variant Collapsing for a Diverse Cohort of FSGS Patients – Povysil, G. (ePoster # PO1673) 
  • Human iPSC-Derived Kidney Micro-Organoids for High-Throughput Disease Modelling in Drug Discovery – Kumar, S.V. (ePoster # PO0613) 
  • AI-Driven Target Identification in CKD – Kumar, S.V. (ePoster # PO0657) 
  • Systematic In Silico Exploration of the Kidney RhoGTPase System Regulation in CKD – Reznichenko, A. (ePoster # PO1982) 
  • Identifying and Clustering Chronic Kidney Disease (CKD) Progression Trajectories Using Machine Learning – Rhodes, K. (ePoster # PO0525) 
  • Reduction in Proximal Tubular Secretion Precedes Reduction in Glomerular Filtration Rate in the Adenine-Induced CKD Model – Kougioumtzidou, E. (ePoster # PO2361) 
  • Lipid Metabolic Profiling of Ex Vivo Isolated Glomeruli as Screening Platform for Modelling Glomerular Metabolic Dysfunction During Renal Disease – Krause, F.N. (ePoster # PO0630) 



References:

1. National Health Service. Symptoms: Chronic kidney disease; 2016 [cited 2020 Aug 10]. Available from: URL: https://www.nhs.uk/conditions/kidney-disease/symptoms/

2. Vos T et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: A systematic analysis for the Global Burden of Disease Study 2016. The Lancet 2017; 390(10100):1211–59.

3. International Diabetes Federation. IDF Diabetes Atlas - 9th Edition. 9th ed.; 2019 [cited 2020 Aug 10]. Available from: URL: https://www.diabetesatlas.org/.

4. Hayes A et al. Changes in Quality of Life Associated with Complications of Diabetes: Results from the ADVANCE Study. Value Health 2016; 19(1):36–41.

5. World Health Organization. WHO World Heart Day: Scale up prevention of heart attack and stroke: World Health Organization; 2019 [cited 2020 Aug 10]. Available from: URL: https://www.who.int/cardiovascular_diseases/world-heart-day/en/.


*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. At ASN 2020, roxadustat data will be sponsored and presented by AstraZeneca, Astellas and FibroGen.




Veeva ID: Z4-28043
Date of Preparation: October 2020