AstraZeneca has announced that the phase 3 DAPA-CKD (Dapagliflozin and Prevention of Adverse outcomes in Chronic Kidney Disease) trial will be stopped early following a recommendation from an independent data monitoring committee (DMC) based on its determination of overwhelming efficacy.
DAPA-CKD is an international, multicentre, randomised, double-blinded trial designed to evaluate the efficacy of dapagliflozin (an SGLT2 inhibitor sold as Forxiga) in participants with CKD stages 2–4, with and without type 2 diabetes. The primary composite endpoint is worsening of renal function defined as a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end-stage kidney disease (ESKD) or cardiovascular (CV) or renal death. Routine assessment of efficacy and safety by the DMC showed benefits earlier than anticipated, resulting in closure of the trial being initiated.
These results are significant as the treatment options for people with CKD are limited, particularly if type 2 diabetes is not present. Dapagliflozin may have the potential to delay the progression of renal failure and prevent CV and renal death in patients with CKD. The results will be submitted for presentation at a medical meeting in the future.
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