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An Overview of the FIGARO-DKD Trial Design


An overview of the FIGARO-DKD trial, which evaluated cardiovascular and renal outcomes in patients with type 2 diabetes and CKD treated with finerenone.


Rajiv Agarwal, MD, MS: The FIGARO-DKD trial is a large cardiovascular [CV] outcomes trial in patients with chronic kidney disease and type 2 diabetes. It’s looking at the effect of finerenone on cardiovascular outcomes in these high-risk patients. By the way of background, I can tell you that these are people who we don’t really think of as at high risk of cardiovascular disease. But as we have known for the last 20 years, if we note a decline in kidney function, it is associated with an increase in CV risk. If we note an increase in albuminuria, we note an increase in CV risk. And when we put the two together, we identify a grade, which is called a KDIGO [Kidney Disease: Improving Global Outcomes] heat map, that tells us the future risk of cardiovascular morbidity and mortality and end-stage kidney disease.

We have known for a long time that patients who have very high albumin, what we used to call macroalbuminuria, are at a very high risk of progressing from early stages of kidney disease to the later stages of kidney disease and end-stage kidney disease. However, when they have moderately elevated albuminuria, or what we call microalbuminuria—somewhere between 30 and 299 mg/g of creatinine—these are people who will probably have a cardiovascular event before they will have a kidney failure event.

In this trial, 62% of patients had an eGFR [estimated glomerular filtration rate] that was 60 or more, and therefore, 62% of patients in the FIGARO trial were simply identified because they had albuminuria. This is the high-risk population that we are studying. We are asking whether MR [mineralocorticoid receptor] blockade versus a standard-of-care placebo on top of ACE [angiotensin-converting enzyme inhibitor] or ARB [angiotensin receptor blocker] use will reduce the incidence of a cardiovascular outcome. In summary, that’s the trial design of FIGARO.

Transcript edited for Clarity

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