What side effects are associated with this type of intervention?

SGLT2 inhibitors, such as empagliflozin, are used to manage hyperglycemia in type 2 diabetes by increasing urinary glucose excretion. Common side effects include an increased risk of urinary tract infections, genital mycotic infections, and an initial decrease in eGFR, which typically recovers. There is also a risk of dehydration and hypotension due to their diuretic effect. Some studies have raised concerns about an increased risk of lower limb amputations, particularly with canagliflozin, although this has not been consistently observed across all SGLT2 inhibitors.

What prior FDA approvals exist?

The FDA has approved several SGLT2 inhibitors, including empagliflozin, canagliflozin, and dapagliflozin, for the treatment of kidney disease, particularly in patients with type 2 diabetes. These drugs work by reducing glucose reabsorption in the kidneys, which not only helps in managing blood glucose levels but also provides renal and cardiovascular benefits. Empagliflozin, in particular, has demonstrated significant reductions in cardiovascular and all-cause mortality in patients with chronic kidney disease. Other related drugs, such as GLP-1 receptor agonists like liraglutide and semaglutide, have also shown favorable outcomes in reducing kidney disease progression and cardiovascular events.

What other types of research exist?

Promising alternatives to Empagliflozin for kidney disease patients include GLP-1 receptor agonists such as Liraglutide, Semaglutide, and Dulaglutide. These medications improve glycemic control, have cardiovascular benefits, and may offer renal protection. Studies have shown their efficacy and safety in patients with renal impairment, making them viable options for treatment in 2024.

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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Empagliflozin for Kidney Disease (EMPA-PD Trial)

Phase 4

Recruiting

Led By Jeffrey Testani, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable peritoneal dialysis prescription

Patients actively undergoing PD with a reliably functioning PD catheter

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 to day 63

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing if empagliflozin can help patients with severe kidney disease on dialysis by reducing their sugar absorption. The medication works by helping the kidneys remove sugar from the blood. Empagliflozin has been shown to improve kidney outcomes and slow the progression of diabetic kidney disease in previous trials.

Who is the study for?

This trial is for adults over 18 with end stage renal disease on peritoneal dialysis, who have been on a stable dialysis prescription for more than 3 months and produce at least 400 ml of urine daily. It's not suitable for those with type 1 diabetes, recent severe hypoglycemia, or infections related to their dialysis catheter.

What is being tested?

The study tests if Empagliflozin can lower glucose absorption in patients undergoing peritoneal dialysis. Participants will either receive Empagliflozin or a placebo in a randomized manner, followed by an open label phase where all get the drug.

What are the potential side effects?

Empagliflozin may cause low blood sugar levels (hypoglycemia), urinary tract infections, dehydration and genital yeast infections. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My peritoneal dialysis treatment plan hasn't changed recently.

Select...

I am currently on peritoneal dialysis with a working catheter.

Select...

I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had peritonitis or an infection in my dialysis catheter recently.

Select...

I have a history of severe diabetes issues in the past 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 to day 63

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 to day 63

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 63 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glucose absorption with empagliflozin vs. placebo

Secondary study objectives

Change in PET test parameters

Change in peritoneal fluid inflammatory markers

Change in plasma glucose levels with empagliflozin vs. placebo- acute study

+3 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Empagliflozin or Placebo in AcuteExperimental Treatment1 Intervention

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.

Group II: Empagliflozin in ChronicActive Control1 Intervention

Chronic phase: On day 8, all participants will receive 10 mg empagliflozin 10 mg x 8 weeks

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Sodium-glucose co-transporter 2 (SGLT2) inhibitors, such as empagliflozin, are a common treatment for kidney disease. They work by reducing glucose reabsorption in the kidneys, which leads to increased glucose excretion in the urine. This mechanism not only helps in controlling blood glucose levels but also provides renal benefits by reducing the workload on the kidneys and lowering intraglomerular pressure. For kidney disease patients, this is crucial as it can slow the progression of kidney damage and reduce the risk of cardiovascular events, which are common complications in these patients.