Express for the treatment of renal anemia, 5 phase 3 clinical trials of GlaxoSmithKline's innovative therapy reached the primary endpoint

▎Editor of WuXi AppTec content team July 16, 2021, GlaxoSmithKline (GSK) announced that its drug daprodustat, 5 clinical trials in the Phase 3 ASCEND R&D project have all achieved positive top lines Result
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Daprodustat is a new oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
These trials are designed to evaluate the efficacy and safety of daprodustat in patients with anemia caused by chronic kidney disease (CKD)
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The data obtained by the Phase 3 ASCEND project showed that in each trial, daprodustat reached its primary efficacy endpoint
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Improve hemoglobin levels in patients with renal anemia who have not received previous treatment, and maintain hemoglobin levels in patients who have received standard therapy erythropoietin stimulators (ESA)
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In addition, the key cardiovascular outcome trials for non-dialysis patients (ASCEND-ND) and dialysis patients (ASCEND-D) also reached their common primary endpoint
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Compared with the standard treatment group, the risk of major cardiovascular adverse events (MACE) in the daprodustat group reached the standard of non-inferiority
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The entire project enrolled more than 8,000 patients who received treatment for up to 3.
75 years
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The full results of the trial will be announced at an upcoming medical conference later this year and will be notified to health regulatory agencies around the world
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In terms of safety, daprodustat is generally well tolerated in non-dialysis and dialysis patients
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The incidence of adverse events after treatment was similar among the treatment groups
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The most common adverse events included hypertension, diarrhea, dialysis hypotension, peripheral edema, and urinary tract infections
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 Image source: 123RF Chronic kidney disease is characterized by progressive loss of renal function, and its risk factors include hypertension, diabetes, obesity, and primary kidney disease
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Moreover, chronic kidney disease is an independent risk factor for cardiovascular disease
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Anemia is an important and common complication of chronic kidney disease
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Due to the decline of renal function, on the one hand, the production of erythropoietin (EPO) is reduced, and on the other hand, the kidney cannot respond adequately to hypoxic stimulation caused by anemia
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In early patients, such as those who have not received dialysis treatment, the disease is often poorly diagnosed and undertreated, resulting in poor clinical outcomes and a heavy burden on patients and the healthcare system
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Daprodustat stabilizes hypoxia-inducible factors by inhibiting oxygen-sensitive prolyl hydroxylase
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Hypoxia-inducible factors can stimulate the release of endogenous erythropoietin, which in turn promotes the proliferation of red blood cells and the transcription of other genes involved in anemia correction
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Daprodustat is currently approved in Japan for the treatment of patients with renal anemia under the trade name Duvroq
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▲The molecular structure of Daprodustat (picture source: Meodipt[Public domain] via Wikimedia Commons) Dr.
Hal Barron, Chief Scientific Officer and R&D President of GSK, said: “I am particularly happy with the results of the trial for dialysis and non-dialysis patients, because the kidneys For patients with anemia, the management of cardiovascular outcomes is very important, and it is necessary to provide a convenient new oral treatment option
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We will continue to analyze the complete Phase 3 ASCEND project related data, and look forward to working closely with regulatory agencies to submit regulatory applications
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"Reference: [1] GSK announces positive headline results from five Phase 3 studies of daprodustat for patients with anaemia due to chronic kidney disease.
Retrieved July 16, 2021, from https:// media/press-releases/gsk-announces-daprodustat-phase-3-headline-results/ Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation
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