What is the mechanism of action of this treatment?

Sodium-glucose co-transporter 2 (SGLT2) inhibitors, such as empagliflozin, work by blocking the reabsorption of glucose in the kidneys, leading to increased glucose excretion in the urine. This not only helps in controlling blood sugar levels but also has beneficial effects on kidney function by reducing hyperfiltration and proteinuria, which are common issues in kidney failure. Additionally, SGLT2 inhibitors have been shown to reduce the risk of hospitalization for heart failure and slow the progression of diabetic kidney disease. These mechanisms are crucial for kidney failure patients as they help in managing both blood glucose levels and kidney health, potentially delaying the progression to end-stage kidney disease and reducing cardiovascular risks.

What side effects are associated with this type of intervention?

SGLT2 inhibitors, such as empagliflozin, are commonly used in the treatment of kidney failure and type 2 diabetes. Known side effects of SGLT2 inhibitors include an increased risk of urinary tract infections, genital infections, and diabetic ketoacidosis. Additionally, there may be an increased risk of hypotension, dehydration, and acute kidney injury. These medications can also lead to electrolyte imbalances, such as hyperkalemia. It is important for patients to be closely monitored for these potential adverse effects during treatment.

What prior FDA approvals exist?

SGLT2 inhibitors, such as Empagliflozin, have been studied for their efficacy in treating conditions related to kidney failure. Empagliflozin, along with other SGLT2 inhibitors like Canagliflozin and Dapagliflozin, has shown benefits in reducing the progression of kidney disease in patients with type 2 diabetes. These drugs work by increasing urinary glucose excretion, which helps to lower blood glucose levels and has been associated with improved kidney outcomes. The FDA has approved these medications primarily for managing type 2 diabetes, but their renal benefits have been recognized in clinical studies, leading to broader consideration for patients with chronic kidney disease.

What other types of research exist?

Promising alternatives to Empagliflozin for kidney failure patients include GLP-1 receptor agonists such as liraglutide, exenatide, dulaglutide, semaglutide, and lixisenatide. These agents improve glycemic control and have shown benefits in patients with renal impairment. Additionally, DPP-4 inhibitors like sitagliptin, linagliptin, and vildagliptin are also viable options due to their safety profile in patients with kidney impairment.

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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Empagliflozin for Kidney Failure (SEED Trial)

Phase 2

Recruiting

Led By David Charytan, MS, MSc

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Recurrent urinary tract infections (>2 episodes/year or antibiotic prophylaxis)

Does not have capacity to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 12

Summary

This trial is testing empagliflozin, a medication that lowers blood sugar, in patients with severe kidney disease who are beginning treatment. The goal is to see if it is safe and effective for these patients. Empagliflozin helps the body get rid of extra sugar through urine.

Who is the study for?

Adults over 18 who recently started hemodialysis for end-stage kidney disease can join this trial. They must be able to consent and, if female and able to have children, show a negative pregnancy test. People with plans for a kidney transplant soon, severe heart failure, recent major cardiovascular events or surgery, certain diabetes types or complications, active serious infections or cancer treatments are excluded.

What is being tested?

The study is testing the safety and potential benefits of Empagliflozin (a diabetes medication) in patients on hemodialysis due to chronic kidney failure. Participants will either receive Empagliflozin or a placebo without knowing which one they're getting for 12 weeks to compare outcomes.

What are the potential side effects?

Empagliflozin may cause low blood pressure, urinary tract infections, dehydration leading to dizziness or fainting spells especially when standing up quickly from sitting/lying down positions; rare but serious side effects include diabetic ketoacidosis even in non-diabetics.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have had more than 2 urinary tract infections in a year.

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I am unable to understand and give consent for medical procedures.

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I have not had major surgery in the last 12 weeks.

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I have had diabetic ketoacidosis in the past.

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I haven't had a heart attack, unstable chest pain, heart surgery, or stroke in the last 3 months.

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I have the most severe form of heart failure.

Select...

I have a rare inherited disorder affecting how my body absorbs sugar.

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I am taking both ACE inhibitors and ARB medications.

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I have Type 1 Diabetes.

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I am allergic to SGLT2 inhibitors or their ingredients.

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I do not have severe liver disease or significantly high liver enzyme levels.

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I am scheduled for a kidney transplant within the next 3 months.

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I produce less than a cup of urine daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in 24-Hour Urine Volume from Baseline to 12 Weeks

Change in Extracellular Volume from Baseline to 12 Weeks

Change in Intracellular Volume from Baseline to 12 Weeks

Secondary study objectives

Change in 24-Hour Ambulatory Blood Pressure from Baseline to 12 Weeks

Change in 24-Hour Urine Albumin Excretion from Baseline to 12 Weeks

Change in Heart Rate Variability from Baseline to 12 Weeks

+6 more

Other study objectives

Recruitment Rate

Withdrawal Rate

Side effects data

From 2019 Phase 2 trial • 80 Patients • NCT03200860

38%

Renal/Urinary

33%

Musculoskeletal

23%

Cardiovascular

23%

Metabolic

15%

Gastrointestinal

15%

Other

Worsening Heart Failure

Respiratory

Worsening Renal Function

S. Aureus Bacteremia

Angioedema

Acute Kidney Injury

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Empagliflozin

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EmpagliflozinExperimental Treatment1 Intervention

Participants with end-stage kidney disease (ESRD) initiating hemodialysis will receive Empagliflozin 10 mg daily for 12 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants with ESRD initiating hemodialysis will receive Empagliflozin-matching placebo daily for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Empagliflozin 10 MG

2016

Completed Phase 4

~990

0 / 13Eligibility 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, work by blocking the reabsorption of glucose in the kidneys, leading to increased glucose excretion in the urine. This not only helps in controlling blood sugar levels but also has beneficial effects on kidney function by reducing hyperfiltration and proteinuria, which are common issues in kidney failure. Additionally, SGLT2 inhibitors have been shown to reduce the risk of hospitalization for heart failure and slow the progression of diabetic kidney disease. These mechanisms are crucial for kidney failure patients as they help in managing both blood glucose levels and kidney health, potentially delaying the progression to end-stage kidney disease and reducing cardiovascular risks.

Class effect for SGLT-2 inhibitors: a tale of 9 drugs.