Please confirm that you would like to log out of Medscape. If you log out, you will be required to enter your username and password the next time you visit.The management of chronic kidney disease in patients with diabetes has been transformed over the past 4 years. But studies have focused mainly on patients with type 2 diabetes , and patients with type 1 diabetes have largely been left out. Health inequalities between these patient groups have been widening.
Understandably, my patients with T1D and CKD are frustrated that they are not eligible for these potentially life-changing treatments for CKD that can reduce the progression of CKD and decrease the risk for adverse cardiovascular and kidney outcomes. It is well known that CKD is an independent risk factor for CV disease. Tragically, most patients with CKD die from a CV event well before they need renal replacement therapy. I share my patients' frustrations.
Hiddo Heerspink, PhD, PharmD, professor of clinical trials and personalized medicine at University Medical Center in Groningen, Netherlands, surveyed the ongoing clinical trials in patients with T1D and CKD. He confirmed that this is a major unmet need and a clear opportunity to develop newer therapies to better treat this hitherto neglected group of individuals.
Such trials are challenging in the context of T1D; surrogate endpoints such as glomerular filtration rate slope or change in albuminuria can be used to overcome this barrier. Unpublished data from the CSG-Captopril trial demonstrated that proteinuria closely follows disease progression and predicts ESKD in T1D. Conversely, early reduction in proteinuria is associated with kidney protection.
FINE-ONE is a currently active phase 3 trial exploring the impact of finerenone in 220 patients with T1D and CKD. Key exclusion criteria include T2D, treatment with SGLT2 inhibitor medications, GLP-1 receptor agonists, or other MRAs. Additionally, those with symptomatic heart failure with reduced ejection fraction and clinical indications for MRA therapy were also excluded. The primary endpoint is change in urinary albumin-to-creatinine ratio from baseline over 6 months.
Finally, the collaborative STENO-1 study is a 5-year intervention study with clinically meaningful endpoints of cardiorenal outcomes in patients with T1D and various cardiorenal profiles. On the basis of their profiles, participants will receive different medications, including semaglutide, sotagliflozin, finerenone, ezetimibe, and PCSK9 inhibitors, to test the concept of personalized medicine.
Source: Healthcare Press (healthcarepress.net)
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