Empagliflozin for Kidney Disease

(EMPA CKD Trial)

Recruiting at 1 trial location

Overseen By Shannen Ubalde, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Washington D.C. Veterans Affairs Medical Center

Must be taking: Empagliflozin

Must not be taking: Diabetes medications

Disqualifiers: Diabetes, Smoking, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Empagliflozin affects kidney health in African American veterans with non-diabetic kidney disease. Researchers are examining specific proteins related to kidney injury that appear in urine. The trial compares Empagliflozin to a placebo to assess its effects on these proteins and overall kidney function. African American veterans without diabetes, who have controlled blood pressure and certain kidney function levels, might qualify to participate. As a Phase 4 trial, Empagliflozin is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on a statin, you need to be on a stable dose for a month. Also, you cannot participate if you are taking any diabetes medications.

What is the safety track record for Empagliflozin?

Research has shown that empagliflozin is generally safe for people with kidney disease. Past studies found that it slows the progression of kidney disease and reduces the risk of heart problems compared to a placebo. Specifically, participants taking empagliflozin experienced a 34% lower risk of kidney failure, a significant outcome.

The treatment has also been well-tolerated by individuals with conditions such as diabetes and obesity. Importantly, no widespread reports of serious side effects have emerged. This makes empagliflozin a promising option for those with kidney issues. Prospective participants should consult a healthcare provider before joining a trial to ensure it is the right choice. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about empagliflozin for kidney disease because it offers a new approach compared to traditional treatments. Most current treatments for kidney disease focus on controlling blood pressure and diabetes to slow down kidney damage. However, empagliflozin works differently by reducing glucose reabsorption in the kidneys, which not only helps control blood sugar but also reduces the stress on the kidneys. This dual action can potentially slow down the progression of kidney disease more effectively, offering hope for better outcomes in patients.

What is the effectiveness track record for Empagliflozin in treating kidney disease?

In this trial, participants will receive either empagliflozin or a placebo. Research has shown that empagliflozin slows the progression of chronic kidney disease (CKD). Studies have found that it lowers the risk of worsening kidney disease and reduces the chances of dying from heart problems compared to a placebo. In trials, participants taking empagliflozin experienced a slower decline in kidney function, even with low levels of protein in their urine. Evidence also indicates that empagliflozin can lead to fewer hospital visits for heart issues. Overall, the data supports empagliflozin's benefits for kidney health, particularly in slowing kidney disease progression. ^{1 2 6 7 8}

Who Is on the Research Team?

Sabyasachi Sen, MD

Principal Investigator

Washington VA Medical Center

Are You a Good Fit for This Trial?

This trial is for African American veterans aged 20-90 with non-diabetic chronic kidney disease, specifically those who have a BMI of 25-45 and controlled blood pressure. They must have an eGFR between 30-90 mL/min/1.73 m2, albuminuria of at least 30 mg/g, and HbA1C levels below 6.5%. Participants need to be able to give informed consent.

Inclusion Criteria

BMI=25-39.9

Blood pressure controlled to ≤140/90

Ability to provide informed consent before any trial related activities are conducted

Exclusion Criteria

I have been diagnosed with diabetes.

Hypersensitivity to empagliflozin or any of the excipients in Jardiance, reactions such as angioedema

I have been diagnosed with Polycystic Kidney Disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Empagliflozin or placebo 10 mg orally daily to study podocyte specific injury markers

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Empagliflozin

Trial Overview

The study tests the effect of Empagliflozin on proteins indicating podocyte injury in urine exosomes versus a placebo. It aims to see if this drug can improve markers related to kidney damage in patients without diabetes by comparing it with standard biomarkers like ACR and estimated GFR.

How Is the Trial Designed?

Group I: Placebo Active Control 1 Intervention

Placebo 10 mg orally daily

Group II: Empagliflozin Active Control 1 Intervention

Empagliflozin 10 mg orally daily

Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease

Approved in United States as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease
• Cardiovascular risk reduction

Approved in Canada as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction
• Chronic kidney disease

Approved in Japan as Jardiance for:

• Type 2 diabetes mellitus
• Heart failure with reduced ejection fraction

Who Is Running the Clinical Trial?

Washington D.C. Veterans Affairs Medical Center

Lead Sponsor

Trials

45

Recruited

18,500+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

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]

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]

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-KIDNEY trial involving 6609 participants, empagliflozin significantly slowed the progression of chronic kidney disease, reducing the chronic decline in kidney function by 50% after an initial dip in eGFR.

The benefits of empagliflozin were observed across various patient groups, indicating that albuminuria levels should not be the sole factor in deciding treatment with SGLT2 inhibitors, as even patients with low albuminuria experienced significant improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial. [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 effectively lowers blood sugar levels in patients with type 2 diabetes by inhibiting glucose reabsorption in the kidneys, resulting in an average reduction of HbA1c by approximately 0.8% without causing hypoglycemia, except in those already on insulin or sulphonylureas.

In addition to improving glycemic control, empagliflozin promotes weight loss (about 2 kg) and lowers blood pressure (systolic by approximately 4 mm Hg), while also providing cardiovascular protection, as demonstrated in the EMPA-REG OUTCOME trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. Scheen, AJ.[2022]

The EMPA-KIDNEY trial is a large-scale study involving 6609 participants with chronic kidney disease (CKD) to assess the efficacy and safety of empagliflozin in reducing the risk of kidney disease progression and cardiovascular death.

Participants included individuals with varying degrees of kidney function and both diabetic and non-diabetic patients, making the results applicable to a broad population at risk for CKD complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial. [2023]

In the EMPA-KIDNEY trial involving 6609 patients with chronic kidney disease, empagliflozin significantly reduced the risk of kidney disease progression or death from cardiovascular causes compared to placebo, with a hazard ratio of 0.72, indicating a 28% lower risk.

Patients taking empagliflozin also experienced fewer hospitalizations for any cause compared to those on placebo, suggesting a potential safety benefit, although there were no significant differences in heart failure hospitalizations or overall mortality between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empagliflozin in Patients with Chronic Kidney Disease. Herrington, WG., Staplin, N., Wanner, C., et al.[2023]

In a study of 26,347 Asian patients with chronic kidney disease (CKD) and diabetes, empagliflozin significantly reduced major adverse cardiac events (MACEs), all-cause mortality, and other serious health issues compared to sitagliptin.

While empagliflozin showed overall safety and efficacy benefits, it was associated with a higher risk of genital tract infections, highlighting the need for careful monitoring in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Safety Analysis of Empagliflozin in Type 2 Diabetes Mellitus Patients with Chronic Kidney Disease versus Normal Kidney Function: A Nationwide Cohort Study in Korea. Jang, HY., Kim, IW., Oh, JM.[2023]

Empagliflozin (Jardiance®) is an effective treatment for type 2 diabetes (T2D) that works by inhibiting the sodium glucose cotransporter-2 (SGLT2), and it also offers cardioprotective and renoprotective benefits, making it particularly suitable for patients with cardiovascular disease (CVD) and chronic kidney disease (CKD).

While empagliflozin is generally well-tolerated and easy to administer, it does have some side effects and contraindications that need to be considered, highlighting the importance of evaluating its benefits against potential risks in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dual role of empagliflozin: Cardio renal protection in T2DM patients. Shafiq, A., Mahboob, E., Samad, MA., et al.[2022]

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