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

ConditionEnd Stage Renal Disease on Dialysis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients actively undergoing PD with a reliably functioning PD catheter

Stable peritoneal dialysis prescription

PD vintage > 3 months

Age >18 years of age

Disqualifiers

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

Use of an SGLT2 inhibitor within the prior 30 days

1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter

Anemia with hemoglobin <8g/dL

Trial design

Design model

Crossover

Treatments tested in this trial

  • Empagliflozin 25 mg vs Placebo

    Drug

    Acute Study- Empagliflozin 25 mg vs Placebo on D1 then alternate therapy on D7

  • Empagliflozin 10 MG

    Drug

    Chronic Study- Empagliflozin 10 mg for 8 weeks

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Empagliflozin or Placebo in AcuteExperimental treatment 1 intervention
Group B: Empagliflozin in ChronicActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Glucose absorption with empagliflozin vs. placebo

Total glucose absorption in grams with empagliflozin vs. placebo

Time frame
Day 0 to Day 63

Secondary outcomes

1

Ultrafiltration volume with empagliflozin vs. placebo- acute study

Ultrafiltration volume (in liters) at 4 hours with empagliflozin vs. placebo.

Time frame
at 4 hours
2

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

Time frame
Day 0 to Day 63
3

Increase in natriuresis with empagliflozin vs. placebo-acute study

Natriuresis determined by FENa

Time frame
Day 0 to Day 63
4

Change in peritoneal fluid inflammatory markers

Change in levels of IL-6 and CA-125 (in pg)

Time frame
Day 0 to Day 63

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

Boehringer Ingelheim

Collaborator

Source ClinicalTrials.gov
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