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Is finerenone effective in diabetic nephropathy?

Is finerenone effective in diabetic nephropathy

Finerenone-FIDELIO-DKD Phase III Clinical Study Results

On October 26, 2020, Bayer held a global media briefing during the American Society of Nephrology’s 2020 Kidney Week to present the results of the FIDELIO-DKD Phase III clinical study for the investigational drug Finerenone. This presentation focused on the significant risks associated with the co-occurrence of chronic kidney disease and type 2 diabetes, shedding light on the latest findings from the FIDELIO-DKD Phase III clinical trial.

Dr. Richard Nkulikiyinka, the Clinical Development Head for Cardiology and Nephrology at Bayer in Germany, introduced Finerenone as an investigational, novel, non-steroidal, selective mineralocorticoid receptor antagonist (MRA). Research has shown that it can prevent various damages caused by the excessive activation of the mineralocorticoid receptor. The overactivation of this receptor leads to inflammation and fibrosis, which are significant factors in the damage to the kidneys and cardiovascular system.

Richard Nkulikiyinka

The FIDELIO-DKD Phase III clinical study, which was recently disclosed, is part of the largest Phase III clinical project conducted to date in patients with chronic kidney disease and type 2 diabetes. Another project called FIGARO-DKD is currently ongoing, aiming to evaluate the effectiveness and safety of Finerenone in reducing the incidence of cardiovascular diseases and mortality when compared to a placebo on top of standard treatment.

Bayer has also announced the initiation of the FINEARTS-HF study, a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. This study will compare Finerenone with a placebo in symptomatic heart failure patients with a left ventricular ejection fraction of ≥40%. Its goal is to validate the superiority of Finerenone over a placebo in reducing cardiovascular death and overall heart failure events (defined as hospitalization or emergency treatment due to heart failure).

Kerry Willis

Dr. Kerry Willis from the National Kidney Foundation stated that chronic kidney disease is the most common complication in diabetes patients, with approximately 40% of type 2 diabetes patients developing chronic kidney disease. Furthermore, patients with both chronic kidney disease and type 2 diabetes face a threefold higher risk of mortality compared to those with type 2 diabetes alone. Diabetic patients can assess their kidney function through two straightforward tests: a urine test for albumin and a blood test for creatinine. The levels of kidney function and protein in the urine can be used to estimate the patient’s risk of developing kidney disease, cardiovascular events, and premature death.

Unfortunately, from past research, it’s evident that only around 20% of diabetes patients undergo the recommended tests for the albumin-to-creatinine ratio and the glomerular filtration rate (GFR). Why don’t doctors perform these tests earlier or more frequently? There are several reasons for this, including a lack of awareness among healthcare providers. However, another significant factor is that, until this year, there weren’t many specific therapies available for preventing or slowing the progression of kidney disease in diabetes patients.

The release of the FIDELIO-DKD Phase III clinical study results can significantly address this issue. We hope that through collective efforts to strengthen testing and the development of new treatment methods, kidney disease patients will be able to live longer, healthier lives in the near future.

Professor Rajiv Agarwal, a member of the FIDELIO-DKD Clinical Study Executive Committee, explains that existing treatment methods primarily focus on hemodynamics and metabolic pathways, without directly targeting the overactivation of the mineralocorticoid receptor. Overactivation of the mineralocorticoid receptor can trigger kidney and heart damage in patients with chronic kidney disease and type 2 diabetes, leading to issues such as inflammation and fibrosis.

Rajiv Agarwal

Finerenone was discovered after screening over a million compounds, and it differs from existing mineralocorticoid receptor antagonists in that it is fundamentally non-steroidal, often referred to as a non-steroidal mineralocorticoid receptor antagonist. Extensive animal studies have shown its effective anti-inflammatory and anti-fibrotic properties in both the kidneys and the heart. Moreover, Phase II clinical trial ARTS-DN demonstrated that it can improve a patient’s proteinuria without being influenced by blood pressure. Hence, when conducting the FIDELIO-DKD clinical study, it was assumed that the MR antagonistic action of this drug would slow the progression of kidney disease in chronic kidney disease and type 2 diabetes patients while reducing the incidence of cardiovascular disease and mortality.

FIDELIO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase III clinical study. Its purpose is to assess the effectiveness and safety of Finerenone, in comparison to a placebo, when added to standard treatment, in reducing kidney failure and preventing the progression of kidney disease. The study enrolled approximately 5,700 patients with chronic kidney disease and type 2 diabetes from over 1,000 clinical centers across 48 countries worldwide.

The results indicate that, compared to a placebo, Finerenone delays the progression of chronic kidney disease in patients with both chronic kidney disease and type 2 diabetes. When added to the maximum tolerated dose of guideline-recommended treatment, Finerenone significantly reduces the risk of the primary composite endpoint by 18% (relative risk reduction, HR 0.82 [95% CI, 0.73-0.93; p = 0.0014]). The primary composite endpoint includes the occurrence of kidney failure, a sustained reduction in estimated glomerular filtration rate to below 40% of baseline for at least 4 weeks, or kidney disease-related deaths, with a median follow-up time of 2.6 years.

The study demonstrates that Finerenone reduces the risk of the primary endpoint events, and the results are consistent across various predefined subgroups. Furthermore, the treatment effect remains consistent throughout the entire study period. In comparison to a placebo, Finerenone also significantly reduces the risk of key secondary endpoint events. Over a median follow-up time of 2.6 years, it lowers the risk of composite events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or heart failure hospitalization, by 14% (relative risk reduction, HR 0.86 [95% CI, 0.75-0.99; p = 0.0339]). Both groups of patients received standard treatment, which includes glucose-lowering therapy and the maximum tolerated dose of renin-angiotensin system (RAS) blockade therapy, such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).

Finerenone demonstrates good tolerability, and its safety profile aligns with observations from previous studies. Throughout the treatment period, the overall adverse events and severe adverse events are similar between the two groups. Most adverse events are mild to moderate in severity. In comparison to the placebo group (34.3%), a lower proportion of patients in the Finerenone group (31.9%) experience severe adverse events. However, the Finerenone group has a higher incidence of adverse events related to hyperkalemia compared to the placebo group, with rates of 18.3% and 9%, respectively. The frequency of severe adverse events related to hyperkalemia is lower in both groups, at 1.6% and 0.4%, respectively. The proportions of treatment discontinuations due to hyperkalemia are 2.3% and 0.9% for the Finerenone and placebo groups, respectively, and there were no hyperkalemia-related deaths in either group.

How to find effective and affordable finerenone tablets

Have you suffered from the physical pain of lower backache and abdominal pain due to the renal function deterioration caused by diabetic kidney disease?

Have you experienced fatigue and weakness because of anemia resulting from diabetic kidney disease, making it difficult to carry out daily activities?

Have you felt headaches, dizziness, and difficulty continuing your day due to high blood pressure brought on by diabetic kidney disease?

Have you dealt with anxiety, depression, and emotional instability due to the long-term management of the disease and treatment?

Have you spent a significant amount of money on treating diabetic kidney disease, causing financial strain on your family?

Have you ever been afraid of needing dialysis to sustain life, potentially compromising your dignity?

Are you afraid of death?

If you wish to avoid the aforementioned consequences, it’s essential to undergo early diagnosis, actively manage diabetes, implement medication, dietary and lifestyle adjustments, and engage in regular monitoring. This approach can help slow down the progression of the disease and reduce the risk of related complications.

It’s widely known that the treatment for type 2 diabetes, RYBELSUS® (semaglutide) tablets, comes with a high cost of up to $995 for 30 tablets. Similarly, the medication for treating diabetic kidney disease, Kerendia finerenone tablets, can be as expensive as $670 for 30 tablets. The exorbitant prices of these medications undoubtedly add to the challenges faced by patients in their daily lives.

Is there an equally effective but more affordable medication available? The answer is LUCIFINE finerenone tablets produced by Lucius Pharmaceuticals. LUCIFINE finerenone tablets are a diabetes kidney disease treatment that has received approval from the Laotian Ministry of Health and is manufactured in Lucius Pharmaceuticals’ GMP factory in Laos, as approved by the U.S. FDA.

LUCIFINE finerenone tablets are not only a legitimately authorized medication but also come at a very affordable price, being only one-third the cost of Kerendia finerenone tablets while delivering the same efficacy.

DKD Care Center serves as the authoritative global distributor for LUCIFINE finerenone tablets, and we possess the necessary authorization certificates from Lucius Pharmaceuticals. The introduction of this new medication comes with significant discounts. If you have been suffering from diabetic kidney disease for an extended period, please don’t hesitate to contact us promptly:

Phone: +852 6993858

Whatsapp: +856 2099383722



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