Study of Empagliflozin Effects on Peritoneal and Kidney Function in Adults with End Stage Renal Disease on Peritoneal Dialysis

What this Trial Is About

This research evaluates the effect of empagliflozin on peritoneal glucose absorption in patients with end stage renal disease ESRD who are on peritoneal dialysis. The study is a randomized, placebo-controlled, acute crossover trial involving about 30 chronic peritoneal dialysis patients. It aims to understand whether empagliflozin can reduce glucose absorption during dialysis and assess its impact on kidney function. Participants will first take a single dose of 25 mg empagliflozin or a matching placebo during the acute phase, with a crossover to the alternate treatment one week later. Following this, all participants will enter an 8-week open-label extension phase where they take 10 mg empagliflozin daily. Study visits and safety visits will include peritoneal equilibration tests PET and other assessments. Over approximately 9 weeks, participants will attend three main study visits and up to four safety visits. Researchers will measure glucose absorption, ultrafiltration volume, plasma glucose levels, natriuresis, peritoneal fluid inflammatory markers, PET parameters, and changes in body water. The study includes close safety monitoring and follow-up to evaluate treatment effects and kidney function.

Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease