Results from Phase 3 DAPA-CKD trial showed that AstraZeneca’s Farxiga (dapagliflozin), along with standard of care, managed a promising rate of reducing the risks associated with chronic kidney disease (CKD).

In the trial, the drug reduced the worsening of renal function or risk of cardiovascular (CV) or renal death by 39% when compared to placebo in CKD patients between stages 2 and 4 exhibiting high urinary albumin excretion. The study showed constant results in patients with and without type-2 diabetes (T2D).

CKD is a progressively serious condition resulting in decreased kidney function and reduced eGFR or markers of kidney damage. The most common causes of the disease include diabetes, hypertension and glomerulonephritis.

AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “With today’s results, Farxiga becomes the first SGLT2 inhibitor proven to significantly prolong the survival of patients with chronic kidney disease with and without type-2 diabetes and we look forward to sharing these data with regulatory authorities around the world.

“Farxiga is also the first medicine in its class to demonstrate benefit in treating both heart failure and chronic kidney disease in patients with and without type-2 diabetes, and reduce the risk of hospitalisation for heart failure and nephropathy in type-2 diabetes.”

DAPA-CKD trial evaluated Farxiga plus standard of care compared with placebo

DAPA-CKD is an international, multi-centre, randomised, double-blinded clinical trial evaluating Farxiga plus standard of care versus placebo, in 4,304 patients with CKD Stages 2-4 and elevated urinary albumin excretion, with and without T2D.

The primary composite endpoint of the trial includes worsening of renal function or risk of death, defined by sustained decline in the estimated glomerular filtration rate (eGFR), onset of ESKD and death from CV or renal failure.

The study satisfied all the secondary endpoints, such as time to first incidence of renal composite, including sustained eGFR decline, ESKD and renal death, the composite of CV death or hHF, and death from any cause.

In the study, patients treated with Farxiga were not as adversely affected when compared to placebo, with no reported diabetic ketoacidosis while placebo group reported two patients. Farxiga showed a consistent safety and tolerability with the well-established previous safety profile of the drug.

Farxiga was granted US regulatory approval in in May 2020, to reduce the risk of CV death and hospitalisation for heart failure (hHF) in adults with HFrEF with and without T2D. The drug is currently being evaluated in DELIVER, DETERMINE, and DAPA-MI trials.

DAPA-CKD trial co-chair David Wheeler said: “The impressive DAPA-CKD trial results are a remarkable development for patients with chronic kidney disease. These data have the potential to transform the standard of care for this patient population, which has a significant unmet need for new and improved treatment options.”