The
CKD is an increasing global health burden affecting 700 million patients worldwide, with an estimated one in seven patients also developing anaemia, resulting in increased morbidity, mortality and reduced quality of life. When not adequately managed in certain patients, it can result in exhaustion and limit the ability to function in day-to-day life. When left untreated or undertreated, anaemia of CKD is associated with poor clinical outcomes and leads to a substantial burden on patients and healthcare systems. There remains an unmet need for convenient treatment options with efficacy and safety comparable to current treatments.
Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), was studied in the ASCEND phase III clinical trial programme, which included five pivotal trials assessing the efficacy and safety of daprodustat for the treatment of anaemia across the spectrum of CKD. All five pivotal trials met the primary endpoints. Results from two trials were published in the
In
About the ASCEND phase III clinical trial programme
The ASCEND programme includes five phase III trials to assess the efficacy and safety profile of daprodustat for the treatment of anaemia of CKD across the disease spectrum. The programme enrolled over 8,000 patients treated for up to 4.26 years. Results from all five trials were presented at the
Results from the two pivotal cardiovascular outcomes studies, ASCEND-ND and ASCEND-D, which investigated patients not on dialysis and on dialysis, respectively, were also published in the
- ASCEND-ND (Anaemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Non-Dialysis) enrolled 3,872 non-dialysis dependent patients with anaemia of CKD who were either switched from the standard of care (ESA) or not currently receiving
- ASCEND-D (Anaemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat-Dialysis) enrolled 2,964 dialysis patients with anaemia of CKD who were switched to receive daprodustat or
Additional results were also published in the
About anaemia of chronic kidney disease
CKD, characterised by progressive loss of kidney function, is an increasing global public health burden.[iii] Risk factors for CKD include hypertension, diabetes, obesity and primary renal disorders.iii Furthermore, CKD is an independent risk factor for cardiovascular disease.iii Anaemia is an important and frequent complication of CKD.[iv] However, it is often poorly diagnosed and undertreated in patients with early-stage CKD, such as those not on dialysis.iv Over 700 million patients suffer from CKD worldwide, and an estimated one in seven have anaemia.[v],[vi] When left untreated or undertreated, anaemia of CKD is associated with poor clinical outcomes and leads to a substantial burden on patients and healthcare systems.iv
About daprodustat
Daprodustat, a HIF-PHI, belongs to a novel class of oral medicines being studied for the treatment of anaemia of CKD in adult patients not on dialysis and on dialysis. Inhibition of oxygen-sensing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the correction of anaemia, similar to the physiological effects that occur in the human body at high altitude. Daprodustat is being developed to provide a convenient oral treatment option for patients with anaemia of CKD.
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References
[i] Singh A, et al. Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis. N Engl J Med. 2021; 385:2313-2324.
[ii] Singh A, et al. Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021;385:2325-2335.
[iii] Hill NR, Fatoba ST, Oke JL, et al. Global prevalence of chronic kidney disease - A systematic review and meta-analysis. PLoS One. 2016;11(7):e0158765.
[iv] St Peter WL, Guo H, Kabadi S, et al. Prevalence, treatment patterns, and healthcare resource utilization in Medicare and commercially insured non-dialysis-dependent chronic kidney disease patients with and without anemia in
[v] Bikbov B, Purcell CA, Levey AS, et al. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017.
[vi] Stauffer ME, Fan T. Prevalence of anemia in chronic kidney disease in
.
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