Finerenone Reduces Albuminuria in Type 1 Diabetes; SGLT2 Inhibitors Outperform GLP-1s for Kidneys

Finerenone met its primary endpoint in reducing albuminuria in type 1 diabetic kidney disease, marking the first successful drug trial in 30 years for this population. Separately, SGLT2 inhibitors showed superior kidney protection compared to GLP-1 medications in type 2 diabetes patients.

Finerenone (Kerendia) significantly reduced albuminuria in adults with type 1 diabetes and chronic kidney disease (CKD), meeting the primary endpoint of the phase III FINE-ONE trial. Over 6 months, the urinary albumin-to-creatinine ratio (UACR) decreased by 34% in participants on finerenone compared with 12% in those on placebo (geometric mean ratio 0.75, 95% CI 0.65-0.87, P<0.001).

The 25% greater decrease in this ratio with finerenone than with placebo over a period of 6 months in the current trial was similar to that previously observed in patients with type 2 diabetes and CKD, a population with baseline risk profiles similar to those in the present population. By month 6, more participants on finerenone achieved a UACR reduction of at least 30% (54.3% vs 32.7% with placebo) or at least 50% (28.4% vs 21.8%).

It's been 30 years since a new drug to delay kidney disease progression in adults with type 1 diabetes was successful in a clinical trial -- the last being the ACE inhibitor captopril in 1993. Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, was approved in 2021 to reduce the risk of kidney function decline and cardiovascular events in CKD due to type 2 diabetes. It gained a second indication in 2025 for heart failure. Bayer said it plans to submit the current data in type 1 diabetes to the FDA this year.

FINE-ONE (Finerenone Efficacy and Safety in Chronic Kidney Disease and Type One Diabetes) randomized 242 participants from nine countries from February 2024 to February 2025 to either oral finerenone (10 or 20 mg per day) or matching placebo. Baseline HbA1c was <10%, eGFR ranged from ≥25 to <90 mL/min/1.73 m2, UACR from ≥200 to <5,000 mg/g, and serum potassium was ≤4.8 mmol/L. All participants were on a stable dose of an ACE inhibitor or angiotensin II receptor blocker. Average age was 52, about a third were female, and nearly three-fourths were white.

Hyperkalemia -- the most common adverse event -- occurred in more finerenone-treated patients (10.1% vs 3.3% with placebo), and two participants discontinued finerenone because of it. Besides hyperkalemia, rates of any adverse events (47.1% vs 49.2%, respectively) and serious events (11.8% vs 11.5%) were comparable between the groups.

Average eGFR change was -5.6 mL/min/1.73 m2 with finerenone and -2.7 mL/min/1.73 m2 with placebo; levels approached baseline after washout. Slightly more participants on finerenone had at least a 30% drop in eGFR (9.2% vs 7.4%).

In separate research on type 2 diabetes medications, sodium-glucose cotransporter 2 inhibitors -- which include Jardiance, Farxiga and Steglatro -- outpaced glucagon-like peptide-1 receptor agonists -- such as Ozempic and Mounjaro -- in reducing kidney disease risk. The study analyzed clinical outcomes from more than 36,000 individuals who initiated SGLT2 therapy and nearly 19,000 who initiated GLP-1 treatment in Denmark between 2014 and 2020.

The researchers calculated a weighted five-year risk of chronic kidney disease for both patient populations, finding a 6.7% risk for the SGLT2 inhibitor group and an 8.2% risk for the GLP-1 cohort. Additionally, in the SGLT2 group, 25.2 per 100 individuals experienced acute kidney injury within five years, compared to 28.7 per 100 individuals in the GLP-1 group. Initiation of GLP-1 therapy was associated with lower rates of albuminuria and mortality than SGLT2s, the study found.

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References

  1. Drug Cuts Albuminuria in Type 1 Diabetic Kidney Disease, Too - MedPage Today · medpagetoday.com
  2. GLP-1 Pill Orforglipron More Effective Than Rybelsus in Late-Stage Diabetes Trial · everydayhealth.com
  3. For treating kidney disease, GLP-1s place second behind other diabetes drugs · beckershospitalreview.com