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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin or Placebo in Acute | Experimental | Acute phase: Participants will receive 25 mg empagliflozin once on Day 0 or Day 7. Participants receive empaglifozin or placebo on Day 0. On Day 7, they will be crossed over to the alternate treatment. |
|
| Empagliflozin in Chronic | Active Comparator | Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 mg vs Placebo | Drug | Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose absorption with empagliflozin vs. placebo | Total glucose absorption in grams with empagliflozin vs. placebo | Day 0 to Day 63 |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrafiltration volume with empagliflozin vs. placebo- acute study | Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo. | at 4 hours |
| Change in plasma glucose levels with empagliflozin vs. placebo- acute study |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veena Rao, PHD | Contact | 203-737-3571 | veena.s.rao@yale.edu | |
| Kara Otis | Contact | 203-737-3571 | kara.otis@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Testani, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | Recruiting | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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Randomized, placebo controlled, acute crossover study of empagliflozin in 30 chronic PD patients, with an 8 week "pre post" open label extension in all 30 patients where they will receive empagliflozin daily.
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| Empagliflozin 10 MG | Drug | Chronic Study- Empagliflozin 10 mg for 8 weeks |
|
Change in plasma glucose levels during PD dwell with empagliflozin vs. placebo- acute study
| Day 0 to Day 63 |
| Increase in natriuresis with empagliflozin vs. placebo-acute study | Natriuresis determined by FENa | Day 0 to Day 63 |
| Change in peritoneal fluid inflammatory markers | Change in levels of IL-6 and CA-125 (in pg) | Day 0 to Day 63 |
| Change in PET test parameters | 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) | Day 0 to Day 63 |
| Change in total body water and extracellular water | Change in total body water and extracellular water, using heaving water (D20) | Day 0 to Day 63 |