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

Launched by YALE UNIVERSITY · Dec 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called empagliflozin on patients with end-stage renal disease (ESRD) who are on peritoneal dialysis. The main goal is to see if empagliflozin can help reduce the amount of glucose absorbed through the peritoneum, which is the lining of the abdominal cavity where dialysis takes place. The study will involve about 30 patients who have been on peritoneal dialysis for at least three months. To be eligible, participants must be over 18 years old and have a functioning PD catheter.

If you decide to participate, you will be randomly assigned to receive either the medication or a placebo (a dummy treatment) for a period of time. After this, everyone will take empagliflozin daily for eight weeks. Throughout the study, participants will be monitored closely to see how the medication affects their kidney and peritoneal function. It's important to note that this trial is not for patients with certain conditions, such as type 1 diabetes or recent infections related to dialysis. This study aims to provide new insights that could improve treatment for patients undergoing peritoneal dialysis.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • 1. Patients actively undergoing PD with a reliably functioning PD catheter
• • 2. Stable peritoneal dialysis prescription
• • 3. PD vintage \> 3 months
• • 4. Age \>18 years of age
• Exclusion Criteria:
• • 1. History of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
• • 2. Use of an SGLT2 inhibitor within the prior 30 days
• • 3. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
• • 4. Anemia with hemoglobin \<8g/dL
• • 5. Inability to give written informed consent or follow study protocol
• • 6. Contraindication to receiving loop diuretics