Empagliflozin Treatment to Preserve Kidney Function in Adults Starting Peritoneal Dialysis A Phase 2 Randomized Controlled Pilot Study

What this Trial Is About

Researchers are evaluating the safety of empagliflozin, a diabetes medication, in patients who have recently started peritoneal dialysis, a treatment for end-stage kidney disease. This study focuses on patients who still produce some urine despite dialysis, as preserving residual kidney function can improve blood pressure control, nutrition, quality of life, and survival. The study is a phase 2 randomized controlled trial aiming to prepare for a larger future trial by assessing safety and feasibility. Participants will be randomly assigned to one of two groups one receiving oral empagliflozin 10 mg daily plus standard care including optimized doses of RAAS inhibitors, and the other receiving standard care alone with optimized RAAS inhibitors. Before randomization, there is a 6 to 8 week run-in period to adjust RAAS inhibitor doses. The treatment period lasts 6 months, during which the effects on kidney function and related health measures will be studied. Throughout the study, participants will have their urine volume, blood pressure, glucose control, and signs of infection monitored at multiple time points. The study will also assess medication adherence, retention rates, and safety outcomes like infections and ketoacidosis. Information collected will help determine if empagliflozin is safe and well tolerated for patients on peritoneal dialysis and support the design of a larger trial. Total participation time includes the run-in and 6-month treatment phases.

Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients