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

End Stage Renal Disease on Dialysis Clinical Trial

— EMPA-PD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05671991
• Other study ID #: 2000031605
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Diseases
• Kidney Failure, Chronic

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