Finerenone & Kidney Disease in Type 1 Diabetes: Hopeful Results

A historic breakthrough offers hope to those who live with the risk of chronic kidney disease (DRC).

For more than three decades, people living with type 1 diabetes and CKD are waiting for an innovation capable of changing the course of one of the most serious complications of the disease.

That wait may be coming to an end with the results of the FINE-ONE study, which revealed the positive impact of veneer nona — a new medicine that works to protect the kidneys — in adults with type 1 diabetes.

The challenge of kidney disease in type 1 diabetes

Type 1 diabetes is a condition autoimmune characterized by the destruction of pancreatic beta cellsresponsible for the production of insulin. Despite technological advances in glycemic monitoring and control, the risk of chronic complications remains high.

Among these complications, chronic kidney disease associated with type 1 diabetes stands out, which affects around 30% of people with DM1. Of these, up to a quarter may evolve into terminal renal failurerequiring dialysis or transplant. In addition to the impact on the kidneys, CKD significantly increases the risk of cardiovascular diseases and is one of the main causes of death in this group of patients.

Until today, treatment was based on controlling blood sugar, high blood pressure e albuminuria with classic medicines such as ACE inhibitors e angiotensin receptor blockers (ARBs).

However, therapeutic options were limited and no specific medication had been approved to slow the progression of CKD in people with type 1 diabetes — until the emergence of veneer nona no FINE-ONE.

What the FINE-ONE study found

FINE-ONE is a phase III clinical study (the last before the drug is approved) conducted in more than 80 research centers in nine countries. He evaluated 242 people with type 1 diabetes and chronic kidney disease, who received veneer nona daily or placeboin addition to standard treatment.

The main objective was to evaluate the change in the amount of protein expelled in urine — an important marker of kidney injury.

After six months, the results were clear: finerenone reduced the amount of protein in urine by 25% in relation to the initial value, and 68% two patients treated achieved a reduction of at least 30% in this amount of protein — an index recognized by American Diabetes Association (ADA) as associated with slower progression of kidney disease.

These results make finerenone the first drug in more than 30 years to show significant efficacy against the progression of chronic kidney disease in patients with type 1 diabetes.

The molecule had already demonstrated consistent results in patients with type 2 diabetesproving the reduction in the risk of kidney failure and of cardiovascular events. FINE-ONE, in turn, expands this knowledge to the population with type 1 diabetes, until now without specific therapeutic alternatives.

+Read also: Save your kidneys: how to prevent and control chronic kidney disease

Safety and tolerability

The medication was well tolerated by the participants. The safety profile of finerenone was consistent with previous studies. Cases of potassium elevation They were more frequent in the group that received the drug (10.1%) than in the placebo group (3.3%), but no fatal cases were recorded and treatment interruption rates were low.

These results reinforce finerenone’s favorable safety profile and its viability as a therapeutic option for people with type 1 diabetes and chronic kidney disease.

For Professor Hiddo Lambers Heerspink, from the University of Groningen, who led the study, the results represent a “historical landmark” in nephrology: “Reducing the amount of protein in urine is strongly associated with a decrease in renal and cardiovascular events. The FINE-ONE results bring new hope to patients facing a high risk of loss of kidney function.”

According to Thyago Moraes, nephrologist at PUC do Paraná and coordinator of the kidney diseases committee of the Brazilian Diabetes Society, after decades without therapeutic advances for people with kidney disease associated with type 1 diabetes, the FINE-ONE study renews hope in the management of this condition, confirming a benefit previously demonstrated in people with type 2 diabetes.

A new chapter for kidney treatment

Based on these results, the expectation is that we will soon have the formal indication of finerenone in leaflet for treatment of chronic kidney disease associated with type 1 diabetes.

If approved, the therapy could represent the first real advance in more than 30 years in preventing the progression of kidney disease in this population — and a new chapter in the integration between cardiology e precision nephrology.