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Effect of Empagliflozin on Peritoneal and Kidney Function in End Stage Renal Disease

Study acronym: EMPA-PD
StatusActive, Not Recruiting
PhasePhase 4
Started2023-03-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status, Study Design, Contacts/Locations v9
Enrollment closed, study ongoing
Final enrollment: 22 participants (planned 30)
Enrollment targetestimated 30→confirmed 22
Study sitesdetails revised at 1 of 1 site
2026-05-18
Study Status v8
Primary completion date2025-12-31→2026-12-31
Completion date2026-06-30→2026-12-31
2025-02-27
Study Status, Contacts/Locations v7
Primary completion date2024-12-31→2025-12-31
Completion date2024-12-31→2026-06-30
Study sitescontacts updated at 1 of 1 site
2024-10-18
Study Status, Eligibility v6
Eligibility criteria-94 characters
[...] tioning PD catheter Stable peritoneal dialysis prescription Chronic loop diuretic usage (at Yale, essentially all patients that make urine are on chronic loop diuretics) PD vintage > 3 months 24 Hour urine output >400 ml Age >18 years of age Exclusion Criteria: History of type 1 d [...] ty to give written informed consent or follow study protocol Contraindication to receiving loop diuretics
2024-05-02
Study Status, Contacts/Locations v5
Re-verified, no change to tracked fields
Show 4 earlier versions
2024-02-06
Study Status v4
Primary completion date2023-12-31→2024-12-31
Completion date2024-07-03→2024-12-31
2023-11-22
Study Status v3
Re-verified, no change to tracked fields
2023-05-01
Not Yet Recruiting→Recruiting Study Status, Study Description, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-04-01→confirmed 2023-03-01
Study sites0→1
Study description+557 characters
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 crosse [...]
2023-03-01
Study Status v1
Start date2023-02-03→2023-04-01
2022-12-22
Original filing
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.
Trial Details
NCT Number NCT05671991
Lead Sponsor Yale University
Collaborators: Boehringer Ingelheim
Conditions End Stage Renal Disease on Dialysis
Enrollment 22 participants
Start Date 2023-03-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-14