More than a quarter of adults with diabetes go on to develop chronic kidney disease (CKD). As a result, diabetes has become the leading cause of kidney failure, with heart disease being the leading cause of death for people with CKD. 

A 2020 study, published in the New England Journal of Medicine, found that a phase III clinical trial for finerenone, a new experimental treatment produced by Bayer, can safely treat diabetic kidney disease without causing adverse cardiac side effects.*

What they did

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (MRA). MRAs regulate water excretion, lower blood pressure, and reduce the amount of fluid surrounding the heart. Finerenone targets and blocks receptors that contribute to inflammation, as well as to scarring in the heart and kidneys.

The randomized, double-blind FIDELIO-DKD trial involved 5,734 participants. The clinical trial was spread over more than 1,000 sites in 48 countries; it represented the largest kidney disease study ever conducted. 

All participants had CKD and type 2 diabetes. Each was randomly assigned to either the experimental group to receive finerenone or to the control group to receive a placebo.

The primary composite outcome was:

• Kidney failure
• Sustained eGFR decrease of at least 40% from baseline
• Death from renal causes

The secondary composite outcome was:

• Death from cardiovascular causes
• Nonfatal myocardial infarction
• Nonfatal stroke
• Hospitalization for heart failure

What they found

The trial demonstrated that finerenone slowed the progression of kidney disease by 18% over an average of 2.6 years. 

Specific findings include:

• A primary outcome event occurred in 17% of the finerenone group (504 out of 2833 participants) and 21.1% of the placebo group (600 out of 2841 participants).
• A secondary outcome event occurred in 13% of the finerenone group (367 out of 2833 participants) and 14.8% of the placebo group (420 / 2841 participants).
• Patients receiving finerenone reported higher levels of potassium than the placebo group (18% vs 9%), but severe potassium-related symptoms requiring exit from the study were rare (2.8% vs 0.9%).

Overall, these results illustrate a significant improvement with finerenone when compared with both the results of the placebo group and the current standard of care.

What it means

The drug is not yet approved for use, pending the results of several more trials, but the research team is excited about the drug’s potential. The new therapy would mean that “patients are able to delay dialysis and, in turn, further delay the possible need for kidney transplants,” according to George Bakris, M.D., Professor of Medicine at the University of Chicago and Director of the Comprehensive Hypertension Center at the University of Chicago Medicine. 

“We now have evidence that doctors can safely slow diabetic kidney disease progression and reduce cardiovascular event rates using finerenone,” said Bakris, who is also first author of the study and leader of the phase III clinical trial. “This is very important for a group of patients who’ve historically had very few options.”

*Heher, A. (2020, Oct. 23). Clinical trial shows experimental drug safely slows progression of diabetic kidney disease. UChicago Medicine. https://www.uchicagomedicine.org/forefront/research-and-discoveries-articles/drug-slows-progression-of-diabetic-kidney-disease