Implications of the FINE-ONE Trial: How Might Recently Presented Data From the 2025 Kidney Meeting Influence the Current Treatment Paradigm for Type 1 Diabetes and CKD?

Announcer:
Welcome to DataPulse from ASN Kidney Week 2025 on ReachMD. This activity, titled “Implications of the FINE-ONE Trial: How Might Recently Presented Data From the 2025 Kidney Meeting Influence the Current Treatment Paradigm for Type 1 Diabetes and Chronic Kidney Disease” is provided by Medcon International.

Dr. Pratley:
Hello from ASN Kidney Week 2025, here in Houston, Texas. I'm Dr. Richard Pratley from the AdventHealth Translational Research Institute, and today I'm going to be reviewing the FINE-ONE trial. This is a trial that I had the privilege to be on the steering committee for, and I think it's a very important trial.

So what was FINE-ONE? FINE-ONE was a study of finerenone in patients with type 1 diabetes and chronic kidney disease. Now, this is a patient population that's at particularly high risk of both kidney disease progression as well as cardiovascular disease. We know that among patients with type 1 diabetes, about 30% will develop chronic kidney disease, and by the age of 50 or 60, about 50% will develop chronic kidney disease. They also have a very high burden of cardiovascular disease.

Unfortunately, this population has been largely neglected. There have been very few trials, and the last successful trial of a medication to slow the progression of kidney disease was captopril in 1993. Despite the fact that there have been lots of advances in type 2 diabetes, the type 1 diabetes population has been largely left behind, and that's why I'm excited about the FINE-ONE study.

So what did FINE-ONE show? What we saw was that there was a 25% reduction in albuminuria over about 7.5 months in patients treated with finerenone compared to patients on placebo.

So what does this mean? Well, it turns out, in the FIDELITY study in patients with type 2 diabetes—over 13,000 patients, by the way—we saw that the albuminuria change explained a great proportion of the kidney disease prevention effect that was seen in that analysis. So the FDA has accepted albuminuria as a bridging biomarker, and hopefully, what they will do is allow this data to give an indication for finerenone to be used in patients with type 1 diabetes and chronic kidney disease to prevent progression.

I'm really excited about these results, because I think it will change the paradigm. We'll offer new treatments to patients with type 1 diabetes that we haven't had in the last few decades, and that will hopefully improve outcomes over the long term. I'm also really hopeful that in the future, there will be more trials in this neglected patient population so that we can do a much better job of addressing their high kidney and cardiovascular disease risk.

So from the ASN Meeting in Houston, Texas, 2025, I'm Dr. Richard Pratley, and I thank you for listening.

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Thank you for listening to this DataPulse from ASN Kidney Week 2025 on ReachMD. This activity is provided by Medcon International. Thank you for listening.