Pilot Study to Evaluate Safety and Effectiveness of Combined Dapagliflozin and Semaglutide Therapy in Adults with Kidney Transplants

What this Trial Is About

Researchers are studying the short-term effects, mechanisms, and safety of a 12-week combination treatment using dapagliflozin and semaglutide in 20 kidney transplant recipients KTR, including those with and without type 2 diabetes. Kidney transplantation improves survival and quality of life in kidney failure patients, but options to protect the heart and kidney in transplant recipients are limited. This study focuses on how these two drugs, known to lower blood sugar and blood pressure and protect kidney function, work together in KTRs. Participants will first receive either semaglutide or dapagliflozin alone for 12 weeks. Semaglutide is given via weekly subcutaneous injections starting at 0.25 mg and increasing to 1 mg over 12 weeks, while dapagliflozin is taken as a daily 10 mg tablet. After this monotherapy phase, participants will receive both drugs combined for another 12 weeks. The study is open-label and randomized with two treatment arms. During the study, researchers will monitor kidney and heart function, blood pressure, liver stiffness, and salt and water removal. Safety will be assessed by tracking events like kidney injury, infections, and other side effects. Measurements will include kidney filtration rates, urine tests, blood sugar control, body composition, and arterial stiffness. Participants will be followed for a total of 24 weeks to evaluate changes from the start to the end of each treatment phase.

The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients