The phase 3 DAPA-CKD trial evaluating dapagliflozin (Farxiga) as a possible treatment to delay the progression of renal failure and prevent cardiovascular (CV)/renal death in patients with chronic kidney disease (CKD) has been stopped early due to “overwhelming efficacy,” according to AstraZeneca.
The multicenter, event-driven, double-blind, placebo-controlled trial compared the effect of dapagliflozin to placebo on renal outcomes and CV mortality in patients with CKD. Patients were randomized 1:1 to receive either dapagliflozin (5mg or 10mg) once daily or placebo in addition to standard of care. The primary end point was a composite of worsening renal function or death (defined as a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate [eGFR], onset of end stage renal disease [ESRD] or CV or renal death) in patients with CKD irrespective of the presence of type 2 diabetes (T2D).
Following a routine assessment of efficacy and safety, the benefits of dapagliflozin were demonstrated earlier than anticipated resulting in the closure of the trial. The decision to stop the trial was made based on the recommendation from the study’s independent Data Monitoring Committee (DMC).
Full trial data will be submitted for presentation at a future medical meeting. The Company plans to initiate discussions for early regulatory submissions. In August 2019, the Food and Drug Administration (FDA) granted Fast Track designation to dapagliflozin for this indication.
Farxiga, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is currently approved as an adjunct to diet and exercise to improve glycemic control in adults with T2D. It is also indicated to reduce the risk of hospitalization for HF in patients with T2D and established CV disease or multiple CV risk factors.
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