AstraZeneca reported successful results from its Phase III DAPA-CKD clinical trial of Farxiga (dapagliflozin) in end stage kidney disease (ESKD).
The trial demonstrated a statistically significant and clinically meaningful effect on a composite of worsening of renal function or risk of death, onset of end stage kidney disease (ESKD) or cardiovascular (CV) or renal death in adults with chronic kidney disease. The trial also hit all secondary endpoints in CKD patients with or without type 2 diabetes.
The trial was an international, multi-center, randomized, double-blinded study of 4,304 patients. It evaluated the efficacy of 10 mg of Farxiga compared to placebo in patients with CKD Stages 2-4 and elevated urinary albumin excretion, with or without type 2 diabetes. Farxiga was dosed once a day in addition to standard of care.
The primary composite endpoint was worsening of renal function or risk of death, which was defined as a composite of an eGFR decline of 50% or greater, onset of ESKD and death from cardiovascular or renal cause. The secondary endpoints included the time to first occurrence of the renal composite, which was 50% or greater eGFR decline, ESKD and renal death, the composite of cardiovascular death or hHF, and death from any causes. The trial was conducted in 21 countries.
“DAPA-CKD is the first trial to demonstrate overwhelming efficacy, including improvement on survival, in chronic kidney disease patients both with and without type 2 diabetes” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D for AstraZeneca. “We look forward to sharing these exciting Farxiga results with the scientific community and health authorities worldwide.”