End Stage Renal Disease on Dialysis
Conditions
Keywords
Peritoneal dialysis
Brief 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.
Detailed description
Participants will undergo three study visits, and up to 4 safety visits, over 9 weeks. At 7 AM in the first study visit, the participants will have taken 25mg empagliflozin once or matching placebo, thus producing peak plasma levels by 10 AM. One week later the participant will return for the crossed over to the alternate study drug. At the conclusion of the 2nd study visit, all participants will be provided with empagliflozin 10mg tabs to be taken daily for 56 days (8 weeks). At each study visit and safety visit, participants will undergo a PET test.
Interventions
DRUGEmpagliflozin 25 mg vs Placebo
Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7
DRUGEmpagliflozin 10 MG
Chronic Study- Empagliflozin 10 mg for 8 weeks
Sponsors
Yale University
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized, placebo controlled, acute crossover study of empagliflozin in 30 chronic PD patients, with an 8 week "pre post" open label extension in all 23 patients where they will receive empagliflozin daily.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose absorption with empagliflozin vs. placebo | Day 0 to Day 63 | Total glucose absorption in grams with empagliflozin vs. placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrafiltration volume with empagliflozin vs. placebo- acute study | at 4 hours | Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo. |
| Change in plasma glucose levels with empagliflozin vs. placebo- acute study | Day 0 to Day 63 | Change in plasma glucose levels during PD dwell with empagliflozin vs. placebo- acute study |
| Increase in natriuresis with empagliflozin vs. placebo-acute study | Day 0 to Day 63 | Natriuresis determined by FENa |
| Change in peritoneal fluid inflammatory markers | Day 0 to Day 63 | Change in levels of IL-6 and CA-125 (in pg) |
| Change in PET test parameters | Day 0 to Day 63 | Change in peritoneal equilibration test parameters, measurement of solute transport across the peritoneal membrane (standard test carried out in PD patients to assess solute trasnport across membrane) |
| Change in total body water and extracellular water | Day 0 to Day 63 | Change in total body water and extracellular water, using heaving water (D20) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeffrey Testani, MD
Yale University
Outcome results
None listed