Empagliflozin for Chronic Kidney Disease

(EMPA-CKD Trial)

Overseen By Monique Cho, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

Must not be taking: SGLT2 inhibitors

Disqualifiers: Diabetes, Dialysis, Infections, Malignancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called empagliflozin to determine if it can aid people with chronic kidney disease (CKD) by improving blood vessel function and exercise ability. While empagliflozin is already known to help diabetic patients, this study examines its effects on CKD patients without significant protein leakage in their urine. Participants will receive either empagliflozin or a placebo (a pill with no active drug) to compare outcomes. Ideal candidates are adults with CKD who have mild to moderate kidney function and do not have diabetes. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have been on SGLT2 inhibitors in the past year, you cannot participate.

Is there any evidence suggesting that empagliflozin is likely to be safe for humans?

Studies have shown that empagliflozin is generally safe for people with chronic kidney disease (CKD). Research indicates that empagliflozin did not cause any new safety issues in patients with type 2 diabetes and advanced CKD. It also seemed to help slow the progression of kidney disease. One study found that empagliflozin reduced the risk of kidney failure by 34%, a significant benefit. Although a small initial drop in kidney function may occur when starting the treatment, it usually leads to better long-term kidney health. Overall, empagliflozin appears well-tolerated and could offer real benefits for kidney and heart health. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic kidney disease?

Empagliflozin is unique because it targets chronic kidney disease by inhibiting the sodium-glucose co-transporter 2 (SGLT2), which reduces glucose reabsorption in the kidneys. Unlike traditional treatments that focus primarily on managing blood pressure and glucose levels, empagliflozin offers a dual benefit of lowering blood sugar while also providing protective effects on kidney function. Researchers are excited about this treatment because it not only helps control diabetes-related kidney damage but also potentially slows the progression of chronic kidney disease, offering a new approach to managing this challenging condition.

What evidence suggests that empagliflozin might be an effective treatment for chronic kidney disease?

Research has shown that empagliflozin helps slow chronic kidney disease (CKD). In this trial, participants will receive either empagliflozin or a placebo. One study found that people taking empagliflozin had a lower risk of worsening kidney disease or dying from heart problems compared to those taking a placebo. Another study showed that empagliflozin reduced the risk of kidney failure by 34%, with benefits observed regardless of initial kidney function. It also slowed CKD progression in people with low protein levels in their urine. Overall, empagliflozin supports kidney health and improves the quality of life for people with CKD. ^{1 3 6 7 8}

Who Is on the Research Team?

Monique Cho, MD

Principal Investigator

VA Salt Lake City Health Care System, Salt Lake City, UT

Are You a Good Fit for This Trial?

This trial is for individuals with chronic kidney disease (CKD) who do not have diabetes and specifically those without heavy urinary protein leakage. It aims to see if a diabetic medication can help improve their condition.

Inclusion Criteria

eGFR 20-59 mL/min

I am 18 years old or older.

Albuminuria <300 mg/g

Exclusion Criteria

Known allergy to empagliflozin

Pregnancy

I am currently receiving treatment for a skin ulcer on my limb.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 10 mg of empagliflozin or placebo for 16 weeks to assess vascular function and physical capacity

16 weeks

3 visits (in-person) at baseline, 8 weeks, and 16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Empagliflozin

Trial Overview The study tests whether Empagliflozin, a drug typically used for diabetes, can benefit blood vessel function and physical performance in non-diabetic CKD patients compared to a placebo.

How Is the Trial Designed?

Group I: Empagliflozin Experimental Treatment 1 Intervention

Matching 10-mg empagliflozin dose will be used.

Group II: Placebo Placebo Group 1 Intervention

The placebo will be encapsulated to look identical to the study drug.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2204233

Empagliflozin in Patients with Chronic Kidney Disease Empagliflozin therapy led to a lower risk of progression of kidney disease or death from cardiovascular causes than placebo.

2. thelancet.com thelancet.com/journals/landia/article/PIIS2213-8587(25)00222-0/fulltext

an individual participant-level meta-analysis The risk of kidney failure was reduced by 34%. Benefits were evident irrespective of the predicted size of the acute dip in eGFR and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7615591/

Effects of Empagliflozin on Progression of Chronic Kidney ... Empagliflozin slowed the rate of progression of CKD among all types of participant in the EMPA-KIDNEY trial, including those with little albuminuria.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589537025002706

Effects of empagliflozin on quality of life and healthcare use ... In summary, 2 years of allocation to empagliflozin in EMPA-KIDNEY increased quality-of-life-adjusted survival and reduced use and cost of other healthcare ...

5. pro.boehringer-ingelheim.com pro.boehringer-ingelheim.com/us/products/jardiance/ckd/efficacy

CKD Efficacy | Jardiance® (empagliflozin) tablets JARDIANCE helps reduce the risk of kidney disease progression and CV death · *. Actual event rates for kidney disease progression or CV death: 16.9% (n=558/3305) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9210861/

Safety of Empagliflozin in Patients With Type 2 Diabetes ... Use of empagliflozin in patients with type 2 diabetes and advanced CKD raised no new safety concerns and may have beneficial effects on the development of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213858723003212

Effects of empagliflozin on progression of chronic kidney ... These analyses show that empagliflozin caused a modest initial drop in kidney function, followed by a substantial slowing of the rate of ...

8. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2022/11/04/16/22/empa-kidney

Study of Heart and Kidney Protection With Empagliflozin The EMPA-KIDNEY trial showed that empagliflozin has salutary effects on renal function and CV mortality among patients with CKD, with or without DM.