Testing the Effects of Dapagliflozin in People with a Kidney Transplant

This study wants to learn how well and safe dapagliflozin works in people who had a kidney transplant and have Type 2 or post-transplant diabetes. We will look at how dapagliflozin affects the function of your kidney, heart, and blood vessels. We are studying the effects/impact of dapagliflozin (a SGLT2 inhibitor) on: - Kidney function - Protein in the urine - Blood vessel function - Heart function


Why this Research Matters

Dapagliflozin is an FDA approved medicine used to treat diabetes, chronic kidney disease, and heart failure. Dapagliflozin works by increasing salt and sugar loss in urine, and has shown to protect heart, kidney, and blood vessel function. However, we do not know if dapagliflozin improves kidney, heart, and blood vessel function in people who have had a kidney transplant and have diabetes. Before you can join the study, you will come for two study visits. At the first visit, we will ask you questions about your health and medical history. We will also do a physical exam and collect some blood and urine for testing. At the second visit, we will do the same tests and procedures that were done at your first visit. You will also have an MRI scan of your kidneys and heart. Before this visit, you will wear a blood sugar monitor for seven days. You will also fast for at least eight hours before this visit. If you qualify and decide to participate, you will be randomly assigned to one of two groups, like flipping a coin. Neither you nor the study team will know what group you are in. One group will take dapagliflozin while the other group will take a placebo. A placebo looks the same and is given the same as the study drug but has no medicine. You will take either the study drug or placebo daily for one year. While you are in the study, you will attend multiple follow up-visits with us to check on how you are doing. At most of these visits, you will have a physical exam, your blood collected, and review of any side effects you may be experiencing. Your participation in this study will last for about one year and you will have up to 14 total study visits (11 virtual, 3 in-person). You and your insurance will need to pay for your routine medical care. You can earn up to $225 for completing all study visits.


Who can Participate

Adult

You may be able to participate in this study if you are between the ages of 18 and 80 years, have had a kidney transplant more than six months ago, have Type 2 or post-transplant diabetes, and are not pregnant or breastfeeding. You may not be able to join the study if you take dapagliflozin now or have Type 1 diabetes.


Study ID

Protocol Number: 23-1360


Meet the Team

Image of Principal Investigator

Jessica Kendrick, MD

Principal Investigator