New results from a multi-national clinical trial showed that a drug already used to treat kidney disease in people with type 2 diabetes also reduces kidney damage in people living with T1D and kidney disease.
Kidney damage in T1D
Kidney damage, also known as nephropathy, is caused by persistently high blood glucose levels damaging the blood vessels in the kidneys.
Kidney disease that lasts over 3 months and gets worse over time is called chronic kidney disease (CKD) and affects 30% of people living with T1D. Having CKD significantly increases your risk of kidney failure and heart complications – so it’s vital that we find treatments for it.
The FINE-ONE clinical trial
In the FINE-ONE clinical trial, a treatment called finerenone was tested on over 100 volunteers from 9 countries across North America, China and Europe who live with T1D and CKD.
The results found that over a 6-month period, finerenone significantly reduced urine albumin-to-creatinine ratio (UACR), when compared to a placebo. High UACR is linked to a greater risk of CKD progressing to kidney failure, so lowering this is key to delaying and preventing further kidney damage.
The participants also didn’t experience any unexpected negative effects, suggesting it’s both safe and effective.
Finerenone is the first treatment in 30 years to achieve positive results for CKD in people living with T1D. This is hugely exciting for people with T1D, who currently have limited treatment options for CKD.
What is finerenone?
In CKD, the hormone aldolsterone is overactive, leading to kidney damage. Finerenone blocks this hormone’s activity to protect the kidneys from further damage.
Finerenone is a once daily tablet that’s already been approved to treat CKD in people with type 2 diabetes.
What’s next?
FINE-ONE is a phase 3 clinical trial, which is the final stage of gathering evidence on a drug’s safety and effectiveness before it can be considered for approval by the government. Bayer (the company that ran the clinical trial) now intends to submit the data for regulatory review, with the goal of making finerenone available for people living with T1D and CKD.
If finerenone gets approved, it would be a fantastic step forward for people living with the burden of both kidney disease and T1D.
The role of Breakthrough T1D
Breakthrough T1D strategically collaborated with Bayer to support the FINE-ONE clinical trial, and we are committed to further collaboration with Bayer to advance therapies for people with T1D. Working with Bayer and other companies will allow us to deliver more treatments to people with T1D to address complications like kidney disease.
Dr Jonathan Rosen, Research Director at Breakthrough T1D International, said:
“People with type 1 diabetes and chronic kidney disease face an immense burden due to their increased risk for both kidney and cardiovascular events. Breakthrough T1D remains committed to collaborating with Bayer to improve kidney care for people with type 1 diabetes.”
