Empagliflozin for Kidney Failure

(SEED Trial)

Recruiting at 1 trial location

Overseen By Finnian R. Mc Causland

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Must not be taking: SGLT2 inhibitors, ACEi and ARB

Disqualifiers: Anuria, Heart failure, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use an SGLT2 inhibitor within 6 weeks before joining the study. Also, you cannot use both an ACE inhibitor and an angiotensin receptor blocker together.

What evidence supports the effectiveness of the drug empagliflozin for kidney failure?

Research shows that empagliflozin can reduce the risk of kidney disease progression and cardiovascular death in patients with chronic kidney disease and type 2 diabetes. It also helps stabilize kidney function over time, even in patients with heart failure. ^{1 2 3 4 5}

Is empagliflozin safe for humans?

Empagliflozin, also known as Jardiance, has been studied for safety in people with type 2 diabetes and chronic kidney disease. Clinical trials have shown that it is generally safe, but patients should be monitored for potential side effects like fluid deficits. ^{1 2 4 5 6}

How does the drug empagliflozin differ from other treatments for kidney failure?

Empagliflozin is unique because it not only helps manage blood sugar levels in diabetes but also slows the progression of kidney disease and reduces the risk of cardiovascular death, making it beneficial for patients with chronic kidney disease and heart failure. ^{1 2 4 7 8}

Research Team

David Charytan, MS, MSc

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

Inclusion Criteria

I am 18 or older and started hemodialysis within the last 6 months.

I am on a thrice-weekly hemodialysis schedule.

I am of childbearing age and have a negative pregnancy test.

Exclusion Criteria

I am currently receiving treatment for cancer, except for certain skin cancers and early-stage cervical cancer.

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Empagliflozin or placebo daily for 12 weeks while initiating hemodialysis

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Empagliflozin 10 MG
• Placebo

Trial Overview 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.

Participant Groups

Group I: Empagliflozin Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Empagliflozin 10 MG is already approved in United States, European Union for the following indications:

Approved in United States as Jardiance for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Approved in European Union as Jardiance for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

Findings from Research

The EMPA-KIDNEY study evaluated the effects of empagliflozin in patients with chronic kidney disease, demonstrating significant benefits in slowing the progression of kidney disease.

This study involved a large cohort of patients, providing robust evidence for the efficacy of empagliflozin as a treatment option for chronic kidney disease, highlighting its potential to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In CKD, once-daily empagliflozin reduced progression of kidney disease or CV death at 2 y. Kwong, YD., Hsu, CY.[2023]

In the EMPA-REG OUTCOME trial, empagliflozin significantly reduced the risk of worsening kidney outcomes and cardiovascular death by 43% in patients with heart failure, demonstrating its efficacy in managing kidney health in type 2 diabetes patients.

Empagliflozin stabilized estimated glomerular filtration rate over time, contrasting with a gradual decline seen in the placebo group, indicating its potential to slow chronic kidney disease progression regardless of heart failure status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empagliflozin Improves Kidney Outcomes in Patients With or Without Heart Failure. Butler, J., Zannad, F., Fitchett, D., et al.[2020]

In the EMPA-REG Outcome trial involving 6952 patients with type 2 diabetes and established cardiovascular disease, empagliflozin significantly reduced the risk of cardiovascular death by 38%, hospitalization for heart failure by 35%, and worsening kidney disease by 39% compared to placebo.

The efficacy of empagliflozin was consistent across different Kidney Disease Improving Global Outcomes (KDIGO) risk categories, indicating that its benefits on cardiovascular and kidney outcomes were not influenced by the patients' baseline chronic kidney disease status, although it was associated with a higher rate of genital infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial. Levin, A., Perkovic, V., Wheeler, DC., et al.[2023]

Empagliflozin, when administered to 15,081 patients with type 2 diabetes and moderate to severe chronic kidney disease (CKD), showed no new safety concerns, with similar rates of serious adverse events compared to placebo.

The treatment was associated with significantly lower risks of hyperkalemia and edema, suggesting potential benefits for patients with advanced CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Tuttle, KR., Levin, A., Nangaku, M., et al.[2022]

Empagliflozin (Jardiance) is now approved for reducing the risk of cardiovascular death and hospitalization in adults with heart failure, even in those without diabetes, highlighting its expanded therapeutic use.

Healthcare providers, including nurses and nurse practitioners, should closely monitor patients for potential adverse effects, particularly fluid deficits, to ensure patient safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Drug Now Approved for Heart Failure. Aschenbrenner, DS.[2023]

A study involving 60 healthy Chinese subjects demonstrated that the test formulation of empagliflozin is bioequivalent to the brand-name drug Jardiance, showing similar pharmacokinetic properties under both fasting and fed conditions.

Both formulations of empagliflozin were generally well tolerated, indicating a good safety profile for the drug in the tested populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, and Bioequivalence of Two Empagliflozin Formulations after Single Oral Administration under Fasting and Fed Conditions in Healthy Chinese Subjects: An Open-label Randomized Single-dose Two-sequence, Two-treatment, Two-period Crossover Study. Chen, G., Zhang, D., Du, A., et al.[2021]

The CANVAS Program study confirmed that canagliflozin has nephroprotective effects similar to empagliflozin, indicating that SGLT2 inhibitors can be beneficial for both diabetic and non-diabetic kidney disease.

Liraglutide treatment also shows potential for nephroprotection by reducing albuminuria and slowing the decline in estimated glomerular filtration rate (eGFR) in certain subgroups of diabetic nephropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chronic Kidney Disease - Update 2018]. Ketteler, M., Wanner, C.[2019]

In a study of 7,624 patients with chronic kidney disease (CKD), those using SGLT2 inhibitors, particularly dapagliflozin, showed a significantly lower risk of experiencing a decrease in estimated glomerular filtration rate (eGFR) by over 40% within one year.

SGLT2 inhibitor users also had a reduced rate of acute kidney injury (AKI)-related hospitalizations compared to non-users, indicating a potential safety benefit of these medications across various stages of CKD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal and Glucose-Lowering Effects of Empagliflozin and Dapagliflozin in Different Chronic Kidney Disease Stages. Lin, YH., Huang, YY., Hsieh, SH., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

In CKD, once-daily empagliflozin reduced progression of kidney disease or CV death at 2 y. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Empagliflozin Improves Kidney Outcomes in Patients With or Without Heart Failure. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Empagliflozin and Cardiovascular and Kidney Outcomes across KDIGO Risk Categories: Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled, Multinational Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Diabetes Drug Now Approved for Heart Failure. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, and Bioequivalence of Two Empagliflozin Formulations after Single Oral Administration under Fasting and Fed Conditions in Healthy Chinese Subjects: An Open-label Randomized Single-dose Two-sequence, Two-treatment, Two-period Crossover Study. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

[Chronic Kidney Disease - Update 2018]. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Renal and Glucose-Lowering Effects of Empagliflozin and Dapagliflozin in Different Chronic Kidney Disease Stages. [2019]