Impact of empagliflozin on kidney function in patients with end stage renal disease on dialysis
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
This study is testing if the medication empagliflozin can improve kidney function in patients with end stage renal disease who are on peritoneal dialysis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05671991 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of empagliflozin on peritoneal glucose absorption in patients with end stage renal disease (ESRD) who are undergoing peritoneal dialysis. It is a randomized, placebo-controlled, acute crossover study involving 30 chronic peritoneal dialysis patients. Participants will receive either empagliflozin or a matching placebo, followed by a crossover to the alternate treatment after one week. Following the crossover, all participants will take empagliflozin daily for an additional eight weeks, with assessments conducted at multiple study visits.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are actively undergoing peritoneal dialysis with a functioning PD catheter.
Not a fit: Patients with a history of type 1 diabetes, recent use of SGLT2 inhibitors, or active infections related to peritoneal dialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve kidney function and overall health outcomes for patients with end stage renal disease on peritoneal dialysis.
How similar studies have performed: Other studies have shown promise with SGLT2 inhibitors in various renal conditions, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Haven, Connecticut
- Yale University — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey Testani, MD — Yale University
- Study coordinator: Veena Rao, PHD
- Email: veena.s.rao@yale.edu
- Phone: 203-737-3571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.