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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05671991
Phase
PHASE4
Status
Recruiting
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Conditions

  • End Stage Renal Disease on Dialysis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Empagliflozin or Placebo in Acute
    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.
  • Active Comparator: Empagliflozin in Chronic
    Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks

Primary Outcome Measure

Glucose absorption with empagliflozin vs. placebo [ Time Frame: Day 0 to Day 63 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510
Veena Rao, PhD

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Yale University· New Haven, CT

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