Dagre Net III DAPA-CKD study plans to terminate early due to overwhelming efficacy in patients with chronic kidney disease

, based on the recommendations of the Independent Data Monitoring Board (DMC), the Phase III study on dagre net prevention of adverse outcomes (DAPA-CKD) in patients with chronic kidney disease was terminated early, based on a clear "overwhelming effect" on patients with chronic kidney diseasein thestudy's routine assessment of theefficacy and safety of the study, the benefits of Dagre net appeare earlier than expected,the clinical study was recommended to be discontinued,AstraZenecawill subsequentlyto startthe end of thestudywork"Treatment options for patients with chronic kidney disease are often limited, especially for those who do not have type 2 diabetes," said Mene Pangalos, executive vice president of research and development at aAstraZeneca BiopharmaceuticalsWe are pleased that the Data Monitoring Board has endorsed the conclusion that patients receiving dagre net treatment can achieve "overwhelming efficacy"In this context, Dagre Net is expected to revolutionize the management philosophy of chronic kidney disease for the benefit of patients worldwide"
we are honored to be part of this study and see the positive recommendations of the Data Monitoring Committee ," said Professor David Wheeler of University College London and Professor Hiddo L Heerspink of the University of Groningen Medical Centre, co-chair of the 's Executive Committee on Clinical Research We look forward to sharing this result with the medical community and chronic kidney patients The main endpoint of the DAPA-CKD study was a compound endpoint consisting of deterioration or death of renal function (defined as the estimated continuous decline in glomerular filtration rate 50% , progresstoward as end-stage kidney disease or cardiovascular disease or kidney death), regardless of whether the patient had type 2 diabetes full data on the study will be presented and published at a recent medical conference AstraZeneca will also immediately communicate with national health regulators to discuss the early submission of registration documents August 2019, the U.S Food and Drug Administration (FDA) awarded Dagre's net fast-track approval pathway to Dagre's ability to delay the progression of kidney failure in patients with chronic kidney disease and prevent cardiovascular or renal death It is reported that Dagre net for the treatment of patients with heart failure indications are being reviewed by the FDA, as well as the European Medicines Agency (EMA) and other regional regulatory agencies - Complete - on DAPA-CKD DAPA-CKD is an international multicenter randomized double-blind study of 4,245 patients, designed to assess the efficacy of 10mg dagre net compared to placebo, 10mg dagre net for patients with chronic kidney disease with or without type 2 diabetes 2-4 patients with elevated urethomyprotein On the basis of standard treatment, Dagre is given once a day The main compound endpoint is the deterioration of renal function (defined as the decline in glomerular filtration by 50%, the ongoing end-stage kidney disease or death due to cardiovascular or kidney causes) The study is being carried out in 21 countries The end-of-effects guidelines in the study scenario and in the DMC section state that, after evaluating all available validity and safety data, DMC has the right to recommend a suspension of the study based on overwhelming efficacy considerations Little M Source: MedSci Original