Research Awards Recipients

Co-Applicant(s):  Andrew Pinto, Ann Young, Bourne Auguste, Christoph Wanner, Christopher Chan, Darrell Ginsberg, David Cherney, Husam Abdel-Qadir, Istvan Mucsi, Javed Butler, Lisa Dubrofsky, Michael Colacci, Nikolaus Marx, Peter Juni, Ron Wald, Ronald Pearlman, Samir Iskan

Lay Abstract

Background: For many years, a renin-angiotensin system inhibitor (RASi) was the only medication that could be used to prevent heart and kidney disease in people with diabetes and kidney disease (DKD). However, we now have 3 additional medications that can prevent heart and kidney disease in people with DKD. These are sodium glucose co-transporter 2 inhibitors (SGLT2i), glucagon like peptide 1 receptor agonists (GLP1RA) and non-steroidal mineralocorticoid receptor antagonists (nsMRA) (see acronyms for examples). These 4 medications can be used at the same time for even more benefit. Yet, few people are given all 4 medicines, in part because no studies have been done on how to use the medicines together.
Purpose: We propose to do a clinical trial to see if a 16 week early start strategy of using 4 medicines in better than usual care. Usual care often involves starting one medicine at a time and rarely using more than 2 medicines. This study will focus on improving care for DKD with the tools and medicines that we know already work.
Our key goals are: 1. Test if the 16-week early strategy for 4 medicines can be used in clinical care for people with DKD based on how many people are taking the medicine 2. Test if we can recruit for a larger clinical trial of the effect of the 16-week protocol on reducing kidney and heart disease events
Method: We will do a pilot clinical trial in people with DKD who we identify based on kidney function and protein in the urine. We will identify participants for our study through working with >100 family medicine clinics. We will include 110 people who will be randomly assigned to a clinic providing the 16-week protocol or a clinic providing usual care.
Outcomes: The main outcomes of our study will be: 1) Use of medicines: If the 16-week early protocol increases use of all 4 medicines. We will see if people in the protocol group are given and take all 4 medicines more than people in the usual care group 2) Finding people to participate in the study: Among the people who can take part in the study, our goal is to have >40% of them agree to join 3) Follow up in the study: Our aim is to make sure that >90% of people taking part in the study can be reached by the end of the study (<10% lost to follow up).
Patient Engagement: We will include patient partners (Pearlman) in our research team and they are involved in all parts of the study. Their lived experience as a patient has the same importance as research evidence. Their insights will help guide how we include people in our study. We will also create a terms of reference and agree on the amount of time they commit to the study and payment for their time.
Relevance to Patients/Community: We have four medications that can protect the kidney and hearts of people with DKD but they are rarely used. A study that focuses on how to combine these medicines will be important to guide clinical care.
Conclusion: A pilot clinical trial to show that a 16 week early start strategy can be done will be the first step towards doing a larger trial of the strategy to improve kidney and heart disease. Acronym List DKD: Diabetic kidney disease Medication Acronym List, How They Work and Examples: RASi: renin-angiotensin system inhibitor. It reduces pressure in the kidney. An example of this medication is ramipril (brand name: altace). SGLT2i: sodium glucose co-transporter 2 inhibitors. It reduces pressure in the kidney. An example is empagliflozin (Jardiance) GLP1RA: Glucagon like peptide 1 receptor agonists. It reduces kidney damage in many ways. An example is semaglutide (Ozempic). nsMRA: non-steroidal mineralocorticoid receptor antagonists. It reduces pressure in the kidney. An example is finerenone (Karendia)