Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
ConditionEnd Stage Renal Disease on Dialysis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
Qualifiers
Patients actively undergoing PD with a reliably functioning PD catheter
Stable peritoneal dialysis prescription
PD vintage > 3 months
Age >18 years of age
Disqualifiers
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
Use of an SGLT2 inhibitor within the prior 30 days
1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
Anemia with hemoglobin <8g/dL
Trial design
Treatments tested in this trial
- Empagliflozin 25 mg vs Placebo
- Empagliflozin 10 MG
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
Boehringer Ingelheim
Collaborator
Source ClinicalTrials.gov