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FINE-ONE: New Hope for CKD and Type 1 Diabetes

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Q & A with Tina Kaur Thethi, MD, MPH

Associate Investigator, AdventHealth Translational Research Institute

Bayer's recent announcement regarding the start of a Phase III study called FINE-ONE with finerenone for adults living with chronic kidney disease (CKD) and Type 1 diabetes has sparked optimism in the medical community. Dr. Tina Kaur Thethi, Associate Investigator at AdventHealth Translational Research Institute and Endocrinologist at the Diabetes Institute, answers questions about the trial's significance and potential impact.

Question: What is Chronic Kidney Disease (CKD)?

Dr. Thethi: CKD involves a gradual decline in kidney function, leading to the accumulation of waste and fluid in the body. Due to these imbalances, advanced stages of CKD can pose serious health risks.

Question: How does CKD impact people with Diabetes?

Dr. Thethi: CKD affects roughly one-third of adults with diabetes, increasing their vulnerability to complications such as kidney failure and cardiovascular issues. The coexistence of conditions like hypertension and high cholesterol compounds these risks. CKD often manifests with an elevated urinary albumin excretion rate, indicating kidney damage. Despite guideline-recommended therapies to control hyperglycemia, hypertension, and albuminuria in people with Type 1 diabetes, studies suggest that as many as 10-25% of patients will progress to end-stage-kidney-disease.

Question: What treatments are available now?

Dr. Thethi: For almost thirty years, there has been no innovative treatment approved to address the high risk of kidney disease progression in adults with CKD and Type 1 diabetes. Traditional therapies often come with undesirable side effects. New strategies are needed to slow the rate of decline in kidney function, which is why this study is vital for people living with CKD and Type 1 diabetes.

Question: What will the FINE-ONE phase III trial investigate?

Dr. Thethi: The FINE-ONE trial will evaluate the effectiveness of finerenone in comparison to a placebo, alongside standard care, for adults living with CKD and Type 1 diabetes. Finerenone, also known as Kerendia, is currently approved for treating CKD associated with Type 2 diabetes. While Type 2 diabetes mainly impacts metabolic functions, Type 1 diabetes results from the destruction of insulin-producing cells in the pancreas, often linked to both genetic and environmental factors. The study's primary objective is to test finerenone's capacity to slow down the progression of kidney disease by reducing albuminuria over a six-month timeframe in patients diagnosed with Type 1 diabetes.

Question: What is the Translational Research Institute's (TRI) involvement with the FINE-ONE clinical trial?

Dr. Thethi:

TRI is one of the international sites for the study. I am a principal investigator, and Dr. Richard Pratley is on the steering committee. We are looking for participants throughout Central Florida who have Type 1 diabetes and have been diagnosed with Chronic Kidney Disease.

To learn more about participating in the FINE-ONE Phase III Clinical Trial, contact Dr. Tina Thethi at [email protected].

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