DAPA-CKD trial for Farxiga is stopped early in patients with chronic kidney disease due to overwhelming efficacy
The decision to stop the trial early was made following a routine assessment of efficacy and safety which showed Farxiga’s benefits earlier than originally anticipated and AstraZeneca will now initiate closure of the trial. The primary endpoint of DAPA-CKD is a composite of worsening of renal function or death (defined as a composite endpoint of greater than 50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end-stage kidney disease (ESKD) or cardiovascular (CV) or renal death) in patients with CKD irrespective of the presence of type-2 diabetes (T2D).
DAPA-CKD: DAPA-CKD is an international, multi-centre, randomised, double-blinded trial in 4,245 patients designed to evaluate the efficacy of Farxiga 10mg, compared with placebo, in patients with CKD stages 2–4 and elevated urinary albumin excretion, with and without T2D. Farxiga is given once daily in addition to standard of care. The primary composite endpoint is worsening of renal function (defined as a composite of an EGFR decline greater than 50%, onset of ESKD and death from CV or renal cause). The trial is being conducted in 21 countries. The efficacy-stopping guideline in the trial protocol and DMC Charter state that after evaluating the totality of the available efficacy and safety data, the DMC may consider recommending that the study be stopped for overwhelming efficacy.
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Bayer’s Phase III cardiovascular outcomes study FIGARO-DKD, evaluating the efficacy and safety of the investigational drug BAY 94 8862 (finerenone) versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) has met its primary endpoint.
Bayer announced that detailed results from the FIDELIO-DKD Phase III study demonstrated that the investigational drug BAY 94 8862 (finerenone) slowed the progression of chronic kidney disease (CKD) in patients with CKD and type 2 diabetes (T2D) compared to placebo. In the study, finerenone significantly reduced the risk of the composite primary endpoint of time to kidney failure