Join Trial Researching New Treatment for Kidney Disease in Type 1 Diabetes
By April Hopcroft
Beginning in March 2024, the FINE-ONE trial will investigate the effectiveness of Kerendia (finerenone), a medication to prevent kidney disease progression in adults with type 1 diabetes. Despite the high prevalence of kidney disease in this population, there are few available treatments approved for it.
Clinical Trials Identifier: NCT05901831
Trial Name: A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE)
Diabetes Type: Adults with type 1 diabetes and kidney disease
Trial Sponsor: Bayer
What is the trial researching?
The study will investigate how well the medication Kerendia (finerenone) prevents worsening kidney disease in people with type 1 diabetes.
Chronic kidney disease (CKD) is a progressive disease, meaning that the condition worsens over time as the kidneys lose their functionality.
The study will also examine how safe Kerendia is in people with type 1 diabetes and CKD. In particular, researchers will monitor the number of participants with hyperkalemia (higher than normal potassium levels), a common concern for people taking CKD drugs.
The study will enroll 220 people. Participants will either receive finerenone or placebo treatment for six months. The study will last approximately 7.5 months, with at least six site visits required to collect blood and urine samples, check vital signs, monitor heart health, and perform physical exams.
Why is this important?
If approved, finerenone would become the first new medication for people with type 1 diabetes and kidney disease in 30 years. The last new treatment for those with type 1 diabetes was for the ACE inhibitor captopril (brand name Capoten) in 1993.
Researchers have recently highlighted the urgent need for more research into treatments for CKD in the type 1 diabetes population. Dr. Hiddo Lambers Heerspink, a professor and clinical trials researcher at the University Medical Center Groningen in the Netherlands, described the alarming rates of severe albuminuria (a sign of kidney disease) progressing to kidney failure and eventually death among people with type 1 diabetes.
People with diabetes and CKD are not only at risk for worsening kidney disease and kidney failure but also for cardiovascular disease. For people with type 2 diabetes, SGLT-2 inhibitors are approved to manage blood glucose as well as reduce the risk of kidney disease progression and heart failure.
However, SGLT-2 inhibitors aren’t approved for type 1 diabetes, leaving this population with few treatment options – despite their high risk for kidney disease and other complications.
Kerendia received FDA approval to treat people with CKD and type 2 diabetes in July 2021 and gained approval in Europe in February 2022. The drug reduces albuminuria, or protein in the urine. Kerendia has been added to the American Diabetes Association’s treatment guidelines, with a Grade A recommendation for slowing the progression of CKD in adults with type 2 diabetes.
Are you interested?
You may be eligible if you:
-
Are at least 18 years old
-
Have been diagnosed with type 1 diabetes and have an A1C of less than 10%
-
Have been diagnosed with chronic kidney disease and meet both criteria:
-
Estimated glomerular filtration rate (eGFR) of 25 or higher and less than 90
-
Urinary albumin creatinine ratio (UACR) of 200 or higher and less than 5,000
-
-
Are taking a stable dose of an ACE inhibitor or angiotensin receptor blocker for CKD
People with type 2 diabetes or those taking an SGLT-2 inhibitor or GLP-1 receptor agonist are not eligible for the study. See a full list of inclusion and exclusion criteria here.
This study will be recruiting in many locations across the U.S., U.K., Canada, China, Denmark, Germany, Italy, South Korea, and Spain anticipated to start in March 2024.
To learn more about this study, contact the study team at clinical-trials-contact@bayer.com or call (+)1-888-84 22937.
Learn more about kidney disease and diabetes here:
