FINE_ONE
Research type
Research Study
Full title
A parallel-group, randomized, prospective, interventional, double-blind, multicenter global Phase 3 study to investigate the efficacy and safety of finerenone versus placebo, in addition to standard of care, in participants with chronic kidney disease and type 1 diabetes
IRAS ID
1008059
Contact name
Sophie Vangheluwe
Contact email
Sponsor organisation
Bayer AG
Research summary
Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys’ ability to work properly, and type 1 diabetes (T1D).
In people with T1D, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of T1D.
The study treatment finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone may reduce the risk of CKD progressively worsening in people with CKD and T1D. For people with CKD and type 2 diabetes, finerenone is already approved for doctors to prescribe.
In this study, researchers want to learn if finerenone works better than placebo in reducing the participants’ kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured.
Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with:
• medical problems (also called treatment-emergent adverse events (TEAEs))
• serious TEAEs. An TEAE is considered ‘serious’ when it leads to death, puts the participant’s life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important
• higher than normal blood levels of potassium (hyperkalaemia).
Depending on the treatment group, the participants will either take finerenone or placebo. Importantly, the participants will also continue to take their regular SOC medicines.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0160
Date of REC Opinion
5 Sep 2023
REC opinion
Further Information Favourable Opinion