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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05671991
Other study ID # 2000031605
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2023
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Yale University
Contact Veena Rao, PHD
Phone 203-737-3571
Email veena.s.rao@yale.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria 1. Patients actively undergoing PD with a reliably functioning PD catheter 2. Stable peritoneal dialysis prescription 3. Chronic loop diuretic usage (at Yale, essentially all patients that make urine are on chronic loop diuretics) 4. PD vintage > 3 months 5. 24 Hour urine output >400 ml 6. 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Empagliflozin 25 mg vs Placebo
Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7
Empagliflozin 10 MG
Chronic Study- Empagliflozin 10 mg for 8 weeks

Locations

Country Name City State
United States Yale University New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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
Secondary 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
Secondary Increase in natriuresis with empagliflozin vs. placebo-acute study Natriuresis determined by FENa Day 0 to Day 63
Secondary Change in peritoneal fluid inflammatory markers Change in levels of IL-6 and CA-125 (in pg) Day 0 to Day 63
Secondary 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
Secondary 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
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