Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
The main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis. This is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week "pre po
| Condition(s) | End Stage Renal Disease on Dialysis |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | The main purpose of the study is to determine if empagliflozin can reduce peritoneal glucose absorption in patients with end stage renal diease (ESRD) on peritoneal dialysis. This is a randomized, placebo controlled, acute crossover study of empagliflozin in an anticipated 30 chronic PD patients, with an 8 week "pre post" open label extension in all 30 patients where they will receive empagliflozin daily. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Yale University |
| Locations | New Haven, Connecticut, United States |
| Start date | 2023-03-01 |
| NCT ID | NCT05671991 |
| Official listing | https://clinicaltrials.gov/study/NCT05671991 |