Vicadrostat + Empagliflozin for Chronic Kidney Disease

Recruiting at 137 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must be taking: ACE inhibitors, ARBs

Must not be taking: SGLT2 inhibitors, MRAs

Disqualifiers: High potassium, Severe liver disease, Dialysis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

416 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. If you are taking an SGLT2 inhibitor, you must stop at least 4 weeks before the study. Also, if you are on a mineralocorticoid receptor antagonist or similar medications, you need to stop at least 14 days before the study.

What data supports the effectiveness of the drug combination Vicadrostat and Empagliflozin for treating chronic kidney disease?

Research shows that empagliflozin, a part of the drug combination, can help slow down the progression of chronic kidney disease and reduce the risk of heart-related deaths. This suggests that empagliflozin may be beneficial for patients with chronic kidney disease. ^{1 2 3 4 5}

Is the combination of Vicadrostat and Empagliflozin safe for humans?

Empagliflozin, a part of the treatment, is generally considered safe and well-tolerated in patients with type 2 diabetes and chronic kidney disease, though it may cause some adverse effects like severe hypersensitivity reactions. There is no specific safety data available for Vicadrostat in the provided research. ^{6 7 8 9 10}

What makes the drug combination of Vicadrostat and Empagliflozin unique for treating chronic kidney disease?

The combination of Vicadrostat and Empagliflozin is unique because Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, not only helps control blood sugar levels but also offers protective benefits for the kidneys and heart, reducing the risk of kidney disease progression and cardiovascular events. ^{1 4 5 6 8}

What is the purpose of this trial?

This study is open to adults with chronic kidney disease (CKD) that is at risk of getting worse. People who have taken a specific type of medication for kidney disease called SGLT2 inhibitor within 1 month before the study or have certain health conditions cannot take part in this study. The purpose of this study is to find out whether a medicine called vicadrostat, used in combination with another medicine called empagliflozin, works in people with chronic kidney disease. In this study, participants are randomly assigned to one of two groups. Participants have an equal chance of being assigned to either group. In one group, participants take the 2 study medicines, vicadrostat and empagliflozin, every day for 3 months. In the other group, participants take placebo and empagliflozin for the first 1.5 months, and then they take vicadrostat and empagliflozin together for the next 1.5 months. The study medicines are taken orally as tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants are in the study for about 4 months. During this time, they visit the study site multiple times. Doctors regularly test kidney function by measuring specific proteins in the blood and urine. The results are compared between the two groups to see whether there are differences between starting the study medicines at the same time or one after the other. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

Adults with chronic kidney disease at risk of worsening, who haven't used SGLT2 inhibitors in the last month. They must be able to consent, use effective birth control if applicable, and have stable doses of certain blood pressure medicines without planned changes.

Inclusion Criteria

I have signed the consent form for this trial.

I am using or willing to use effective birth control if I can have children.

My kidney function is low but stable, based on recent tests.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to take either vicadrostat and empagliflozin or placebo and empagliflozin for 3 months

3 months

Multiple visits to the study site

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Empagliflozin
• Vicadrostat

Trial Overview The trial tests vicadrostat combined with empagliflozin against a placebo plus empagliflozin for CKD treatment. Participants are randomly assigned to start both drugs together or one after the other over a period of 3 months.

Participant Groups

Group I: Vicadrostat + empagliflozin Experimental Treatment 2 Interventions

Group II: Placebo followed by vicadrostat + empagliflozin Placebo Group 3 Interventions

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead 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 a study involving 624 participants with stage 4 chronic kidney disease (CKD), dapagliflozin significantly reduced the risk of kidney failure and prolonged survival, showing a 27% reduction in the primary composite endpoint compared to placebo.

Dapagliflozin was found to be safe, with similar rates of serious adverse events between the treatment and placebo groups, indicating that it can be an effective option for patients with advanced CKD without increasing risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Dapagliflozin in Stage 4 Chronic Kidney Disease. Chertow, GM., Vart, P., Jongs, N., et al.[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]

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]

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]

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 is effective in improving glycemic control in patients with type 2 diabetes mellitus (T2DM) by increasing urinary glucose excretion, which also leads to weight reduction and lower levels of glycated hemoglobin (HbA1C).

Beyond its use in diabetes, empagliflozin has shown significant benefits in heart failure treatment, reducing hospitalizations and cardiovascular deaths, while also providing nephroprotective effects, although it has some limitations and potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Insights into the Use of Empagliflozin-A Comprehensive Review. Forycka, J., Hajdys, J., Krzemińska, J., et al.[2023]

In a study of 213 patients with type 2 diabetes and chronic kidney disease, urinary tract infections and genital mycotic infections were the most common adverse events associated with SGLT2 inhibitors, occurring at rates of 62.1 and 58.0 events per 1000 person-years, respectively.

Despite these adverse events, SGLT2 inhibitors led to favorable changes in kidney function markers, with significant decreases in urine albumin-to-creatinine ratios and hemoglobin A1c percentages, indicating their efficacy in managing diabetic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events of Sodium-Glucose Cotransporter-2 Inhibitors in Chronic Kidney Disease: A Retrospective Chart Review. Choi, H., Nguyen, LA., Wan, J., et al.[2022]

Dapagliflozin, used to treat type 2 diabetes, showed only small and temporary reductions in kidney function (eGFR) at week 1, which returned to baseline by week 24 and remained stable up to 102 weeks, indicating its renal safety.

The frequency of renal adverse events with dapagliflozin was similar to that of placebo, with very few serious events reported, suggesting that dapagliflozin does not increase the risk of acute renal toxicity in patients with normal or mildly impaired kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of dapagliflozin on renal function in patients with type 2 diabetes. Kohan, DE., Fioretto, P., Johnsson, K., et al.[2021]

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

Effects of Dapagliflozin in Stage 4 Chronic Kidney Disease. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial. [2023]

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

Comparative Effectiveness of the Sodium-Glucose Cotransporter 2 Inhibitor Empagliflozin Versus Other Antihyperglycemics on Risk of Major Adverse Kidney Events. [2022]

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

Empagliflozin in Patients with Chronic Kidney Disease. [2023]

6. 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]

7. Switzerland 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. [2023]

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

New Insights into the Use of Empagliflozin-A Comprehensive Review. [2023]

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

Adverse Events of Sodium-Glucose Cotransporter-2 Inhibitors in Chronic Kidney Disease: A Retrospective Chart Review. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

The effect of dapagliflozin on renal function in patients with type 2 diabetes. [2021]