Vicadrostat + Empagliflozin for Chronic Kidney Disease

Recruiting at 209 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a combination of two medicines, vicadrostat (a new potential drug) and empagliflozin (an SGLT2 inhibitor), can slow the progression of chronic kidney disease (CKD). Participants will take these medicines as tablets and undergo regular kidney function tests. The trial compares two groups: one takes both medicines from the start, while the other begins with one medicine and adds the second later. This trial suits adults with CKD who haven't used an SGLT2 inhibitor in the past month. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of vicadrostat and empagliflozin is under study for safety in people with chronic kidney disease (CKD). Previous studies in people with CKD suggest that this combination might improve kidney function. Tested in clinical settings, it has shown promising results for kidney health.

Empagliflozin is already approved for other conditions, like type 2 diabetes, and studies show it is generally well-tolerated. The side effects in those studies were similar to those taking a placebo, indicating few serious safety concerns. Earlier research has examined vicadrostat's effects on the heart and kidneys. While specific side effect details for vicadrostat alone aren't provided here, thorough testing ensures its safety.

This trial is in the middle phase of research, meaning the treatment has passed initial safety tests but is still being evaluated for safety in a larger group. This phase helps researchers understand how well people tolerate the treatment and any possible side effects. Participants in this trial will be closely monitored to ensure their safety and to track any unwanted effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Vicadrostat and Empagliflozin for chronic kidney disease because it offers a novel approach compared to current treatments like ACE inhibitors and ARBs. Vicadrostat targets a different pathway by inhibiting the enzyme HIF-PH, which is involved in oxygen sensing and can potentially protect kidney cells from damage. Empagliflozin, on the other hand, is part of the SGLT2 inhibitor class that not only lowers blood sugar but also reduces pressure in the kidneys, offering a dual benefit. Together, these treatments promise an innovative and potentially more effective strategy for managing chronic kidney disease.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

This trial will evaluate the combination of vicadrostat and empagliflozin for treating chronic kidney disease (CKD). Research has shown that using vicadrostat with empagliflozin may help treat CKD. Studies have found that this combination can significantly lower albuminuria, a sign of kidney damage, in people with CKD. Specifically, the combined treatment led to larger reductions in the urinary albumin-to-creatinine ratio (UACR), a key measure of kidney health. These findings suggest that using both drugs together could improve kidney health in those with CKD. Participants in this trial will receive either the combination of vicadrostat and empagliflozin or a placebo followed by the combination treatment. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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 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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39533115/

a rationale for the EASi-KIDNEY trial Phase II data from 586 patients with albuminuric CKD have shown that 10 mg of an ASi, vicadrostat (BI 690517), reduced urine albumin-to- ...

2. academic.oup.com academic.oup.com/ndt/article/40/Supplement_3/gfaf116.0480/8295047

#3201 Effects of vicadrostat with and without empagliflozin in ... Vicadrostat with or without empagliflozin reduced albuminuria irrespective of baseline BMI dichotomized at 30 kg/m2 in participants with CKD and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06926660

NCT06926660 | A Study to Test Whether Vicadrostat in ... 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 ...

4. kireports.org kireports.org/article/S2468-0249(24)02524-5/fulltext

WCN25-2620 CUMULATIVE EFFECTS OF THE ... Larger UACR reductions across all doses of vicadrostat were achieved in participants with CKD who received both active components (vicadrostat+empagliflozin) ...

5. boehringer-ingelheim.com boehringer-ingelheim.com/human-health/chronic-kidney-disease/easi-kidney-phase-iii-trial-people-ckd

EASi-KIDNEY™ Phase III trial for people with CKD The combined use of vicadrostat with empagliflozin has already shown promising results in a Phase II trial in chronic kidney disease in 2023, with full data ...

6. academic.oup.com academic.oup.com/ndt/article/40/6/1175/7896419

The potential for improving cardio-renal outcomes in chronic ... Safety of empagliflozin in patients with type 2 diabetes and chronic kidney disease: pooled analysis of placebo-controlled clinical trials.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06926660

NCT06926660 | A Study to Test Whether Vicadrostat in ... 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 ...