The results, which were simultaneously published in the New England Journal of Medicine and presented at the American Society of Nephrology’s Kidney Week 2020 conference, show that investigational medicine finerenone has noticeable benefits for the kidneys and in patients with chronic kidney disease and type 2 diabetes the cardiovascular system has.
The phase III study with 5,700 people was conducted by Dr. George Bakris, professor of medicine at the university University of Chicago and Director of the Comprehensive Hypertension Center at the University of Chicago Medicine. The study, conducted at more than 1,000 locations in 48 countries, was the largest ever research on the disease, affecting millions of people in the United States alone. More than 1/4 of adults with diabetes eventually develop chronic kidney disease, which makes diabetes the leading cause of kidney failure.
“We now have evidence that using finerenone, a novel nonsteroidal mineralocorticoid receptor blocker that has not yet been approved by the FDA, clinicians can safely slow the progression of diabetic kidney disease and reduce cardiovascular event rates. This is very important for a group of patients who have had very few options in the past, ”Bakris said. “This promising target for a new therapy means that patients can delay dialysis and thus further delay the possible need for kidney transplants. The reduction in cardiovascular events is an added bonus for slowing the progression of kidney disease. ”
Finerenone, manufactured by Bayer, is a nonsteroidal, selective mineralocorticoid receptor (MR) antagonist. The drug has not yet been approved for use, but is being investigated in a number of clinical trials, including FIGARO, which will be completed for cardiovascular outcomes next year. It directly targets and blocks receptors that contribute to inflammation and scarring of the heart and kidney. Kidneys filter waste and water from the body and also play a role in controlling blood pressure. If damaged, it can result in a retention of waste and fluids in the body.
The study, called FIDELIO-DKD (FInerenon to Reduce kiDnEy Disease and Disease Progression in Diabetic Kidney Disease), showed that the drug was significantly better than a placebo and that kidney disease progression compared to a median of 2.6 years current standard care slowed down by 18%.
While patients receiving finerenone reported higher potassium levels (18% versus 9% with a placebo), serious potassium-related side effects that required discontinuation were rare and occurred in 2.8% of patients versus 0.9% of controls. High potassium levels can lead to heart rhythm problems
Bayer announced earlier this year that the study had met its composite primary kidney endpoint and its key composite secondary cardiovascular endpoint. However, the full results of the study were not released until October 23, 2020. The study was randomized, double-blind, and placebo-controlled.
The paper, Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes, was published in the New England Journal of Medicine. Other authors are Rajiv Agarwal, Stefan Anker, Bertram Pitt, Luis M. Ruilope, Peter Rossing, Peter Kolkhof, Christina Nowack, Patrick Schloemer, Amer Joseph and Gerasimos Filippatos. Bakris received funding from Bayer through UChicago Medicine to support the research.