| Trial ID: | L0942 |
| Source ID: | NCT05671991
|
| Associated Drug: |
Empagliflozin 25 Mg Vs Placebo
|
| Title: |
Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease
|
| Acronym: |
EMPA-PD
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease on Dialysis
|
| Interventions: |
DRUG: Empagliflozin 25 mg vs Placebo|DRUG: Empagliflozin 10 MG
|
| Outcome Measures: |
Primary: Glucose absorption with empagliflozin vs. placebo, Total glucose absorption in grams with empagliflozin vs. placebo, Day 0 to Day 63 | Secondary: 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, 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
|
| Sponsor/Collaborators: |
Sponsor: Yale University | Collaborators: Boehringer Ingelheim
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
|
| Start Date: |
2023-03-01
|
| Completion Date: |
2026-06-30
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-04
|
| Locations: |
Yale University, New Haven, Connecticut, 06510, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05671991
|
