New Study to be Unveiled in Boston Shows Promising Treatment for Anemia
Presentation will be shared at National Kidney Foundation’s Spring Clinical Meetings
April 6, 2022, New York, NY — New research that shows promise in treating anemia in people with kidney disease will be unveiled at the National Kidney Foundation’s Spring Clinical Meetings in Boston April 6-10.
The late-breaking presentation of the research will be shared, both virtually and in-person, with thousands of scientists, nephrologists, and professionals at the largest gathering of kidney care professionals in North America. According to the research investigators, daprodustat could represent an oral alternative to erythropoiesis-stimulating agents (ESA) for treating anemia of chronic kidney disease (CKD) in both dialysis and non-dialysis patients.
“Anemia is an important and frequent complication of chronic kidney disease, an increasing global health burden affecting 700 million patients worldwide with 1-in-7 patients also developing anemia that may impact quality of life and increase complications in these patients, said lead author of the study Ajay Singh, associate dean of Harvard Medical School. “Standard of care treatment for anemia includes iron and erythropoiesis-stimulating agents (ESAs). Previous clinical trials with ESAs have raised safety concerns when normalizing hemoglobin, and they have demonstrated no clear benefit in quality of life. Given these concerns with ESAs, paired with the need for injection, more convenient, efficacious, and safe treatments for anemia are needed for patients.”
The development of daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for patients with anemia of CKD, is based on Nobel Prize-winning science that demonstrated how cells sense and adapt to oxygen availability. The ASCEND program included five phase III clinical trials to investigate the efficacy and safety of daprodustat across a spectrum of CKD patients.
The presentation at the conference will include key efficacy and safety data from two well-powered cardiovascular outcome trials (CVOTs), ASCEND-ND and ASCEND-D, as well as a dedicated trial in incident dialysis patients (i.e., patients that are new to dialysis and new to chronic ESA therapy), in more than 7,000 patients across 41 countries.
Daprodustat met its primary efficacy endpoint in each study, demonstrating an improvement in hemoglobin (Hb or Hgb) levels in untreated patients and maintaining Hgb levels in patients treated with an ESA, a standard treatment option in patients with anemia of CKD. In addition, the key cardiovascular outcomes studies for non-dialysis (ASCEND-ND) and dialysis patients (ASCEND-D) demonstrated that daprodustat was non-inferior when compared to an ESA in the risk of MACE, the co-primary endpoint of both studies
These two trials are part of the broader ASCEND phase III clinical trial program that has demonstrated that daprodustat is consistently efficacious and safe in achieving and maintaining hemoglobin levels for patients living with anemia due to CKD, regardless of their dialysis status, compared to standard of care ESA. The ASCEND program was designed in discussion with regulators, as well as leading nephrologists and cardiologists, to reflect the management of anemia for patients.
The program was anchored by two well-powered, cardiovascular outcome trials – ASCEND-ND and ASCEND-D: The ASCEND-ND (Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non-Dialysis) trial enrolled 3,872 non-dialysis dependent patients with anemia associated with CKD who were either switched from standard of care (ESA) or not currently receiving ESA therapy to receive daprodustat or ESA control (darbepoetin alpha). Iron management protocols were instituted across both arms. Results showed daprodustat improved or maintained hemoglobin (Hb or Hgb) levels (between 10-11.5 g/dL) for these patients.
Results from the key cardiovascular outcomes studies were published in the New England Journal of Medicine in November 2021 and included non-dialysis (ASCEND-ND) and dialysis (ASCEND-D) patients.
Daprodustat is currently approved in Japan as Duvroq for patients with renal anemia and is currently under review by the European Medicines Agency (EMA). Regulatory filings are anticipated to continue throughout 2022 with health authorities worldwide.
NKF Spring Clinical Meetings
For more than 30 years, nephrology healthcare professionals from across the country have come to NKF’s Spring Clinical Meetings to learn about the newest developments related to all aspects of nephrology practice; network with colleagues; and present their research findings. The NKF Spring Clinical Meetings are designed for meaningful change in the multidisciplinary healthcare teams’ skills, performance, and patient health outcomes. It is the only conference of its kind that focuses on translating science into practice for the entire healthcare team. This year’s event will be held in Boston, April 6-10.
About Kidney Disease
In the United States, 37 million adults are estimated to have kidney disease, also known as chronic kidney disease (CKD)—and approximately 90 percent don’t know they have it. 1 in 3 adults in the U.S. are at risk for kidney disease. Risk factors for kidney disease include: diabetes, high blood pressure, heart disease, obesity,and family history. People of Black/African American, Hispanic/Latino, American Indian/Alaska Native, Asian American, or Native Hawaiian/Other Pacific Islander descent are at increased risk for developing the disease. Black/African American people are more than 3 times as likely as White people to have kidney failure. Hispanics/Latinos are 1.3 times more likely than non-Hispanics to have kidney failure.
NKF Professional Membership
Healthcare professionals can join NKF to receive access to tools and resources for both patients and professionals, discounts on professional education, and access to a network of thousands of individuals who treat patients with kidney disease.
About the National Kidney Foundation
The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S. For more information about NKF, visit www.kidney.org.