Research Awards Recipients

Lay Abstract

Background: People living with kidney disease are also at high risk for developing cardiovascular disease. Glucagon-like peptide-1 receptor agonists (GLP1RA) such as semaglutide are medications that help lower blood sugar, cause weight loss and have been shown to protect against heart and kidney disease in people with type 2 diabetes. However, their effects in people who are receiving dialysis remain unknown because these people were not included in the major clinical trials that studied this class of medication. This means we do not know if these medications are safe or effective for people with kidney failure who require dialysis. Similarly, finerenone, a medication that slows kidney disease progression and reduces heart disease risk, may increase potassium levels in the blood, which can be dangerous. While clinical trials suggest this risk is low, real-world data is needed to confirm its safety when used outside of controlled research settings. Our studies aim to address these knowledge gaps and provide important safety information on these medications for both patients and healthcare providers.

Purpose: The first research study is a clinical trial called GUARD-1, which will determine whether it is possible to conduct a large-scale study of GLP1RA in patients on dialysis. The second part of this research consists of two safety studies using health data from all patients in Ontario to look at the safety of both GLP1RA and finerenone. These studies will help us understand whether these medications increase the risk of serious health issues such as cancer, gallbladder disease, vision problems, and dangerously high potassium levels. By studying large numbers of patients, we can provide clear answers about the risks and benefits of these medications in real-world settings.

Methods: GUARD-1 is a clinical trial that will recruit 100 dialysis patients from hospitals across Canada. Patients will be randomly assigned to receive either a GLP1RA called semaglutide or usual care. We will monitor how well patients stick to the treatment, whether they experience side effects, and whether we can follow them for the full 26-week study period. These factors will help us decide if a larger trial is feasible. For the second part of our research, we will analyze health records from Ontario to compare patients who start taking GLP1RA and finerenone. We will look at the risk for low blood sugar, pancreatitis, gallbladder disease, eye issues related to diabetes, and cancer in people who are taking GLP1RA. For patients taking finerenone, we will look at the risk of high potassium levels. Anticipated Outcomes: We expect that GUARD-1 will provide critical information on whether a larger trial is feasible and help us understand the safety of GLP1RA in dialysis patients. Our safety studies on GLP1RA and finerenone will help answer questions that patients are already asking in clinic about the long-term safety of these medications.

Patient Engagement: Our research is designed with input from patient partners from Can-SOLVE CKD who have firsthand experience with diabetes and kidney disease. These patient partners will help guide study design and assist in communicating findings to the broader community. Patient partners have already been involved in the development of GUARD-1.

Relevance to Patients/Community: Kidney disease affects over 700 million people worldwide. Patients on dialysis have a particularly high risk of heart disease. Our study GUARD-1 will help provide information on whether GLP1RA can be used safely in people receiving dialysis. Our safety studies use on medications that are increasingly being used in patients living with kidney disease will help patients and doctors make informed decisions regarding treatment.

Conclusion: Understanding the safety and how well medications work essential for improving patient care. Our research will provide valuable information on GLP1RA and finerenone, filling critical gaps in knowledge about their safety and potential benefits for people with diabetes and kidney disease. Glossary of Scientific Terms and Acronyms: GLP1RA (Glucagon-like peptide-1 receptor agonists): A class of diabetes medication which is now used for patients living with kidney disease and is also popularly known to cause weight loss. One commonly used GLP1RA is semaglutide (Ozempic). Finerenone: A new medication used for patients with diabetes and kidney disease that may help slow disease progression and reduce heart disease risk.