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Study of vicadrostat and empagliflozin given together or separately in people with chronic kidney disease to test safety and effectiveness

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study focuses on people with chronic kidney disease who are at risk of their condition getting worse. The study will test two medications: vicadrostat and Jardiance (also known as empagliflozin). Both medications are taken as tablets by mouth. The study aims to determine if taking these two medications together from the start works better than starting them at different times.

The study will compare two different approaches to taking these medications. In one approach, participants will start both medications at the same time. In the other approach, participants will start taking one medication first and add the second medication later. Some participants will receive a placebo instead of vicadrostat. The study will last for 14 weeks, during which participants will take their assigned medications daily.

Throughout the study, doctors will monitor how well the kidneys are working by measuring kidney function through blood tests. They will also check blood pressure and other health indicators to ensure the medications are safe and working as intended. This research could help determine the best way to give these medications to people with chronic kidney disease in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication period

    You will begin taking empagliflozin (Jardiance) 10 mg tablets once daily by mouth

    This medication is used to help manage chronic kidney disease

    You must continue taking your current blood pressure medication (ACE inhibitor or ARB) at the same dose

  2. Step 2

    Treatment groups assignment

    You will be randomly assigned to one of two groups:

    Group 1: Start taking vicadrostat tablets at the same time as empagliflozin

    Group 2: Start taking vicadrostat tablets at a later time during the study

    Neither you nor your doctor will know which group you are in

  3. Step 3

    Regular monitoring - Week 6

    Your kidney function will be checked through blood and urine tests

    The amount of protein in your urine will be measured (UACR test)

    Your blood pressure will be monitored

  4. Step 4

    Follow-up assessment - Week 12

    Your kidney function will be measured again

    Your blood pressure will be checked

    The level of potassium in your blood will be tested

  5. Step 5

    Final evaluation - Week 14

    Final measurement of your kidney function (eGFR test)

    This test shows how well your kidneys are filtering waste from your blood

    The results will be compared to your initial kidney function tests

Who can join the trial?

10 criteria

  • Must be at least 18 years old or meet the legal age of consent in your country if it is higher than 18 years
  • Must provide written informed consent before participating in the trial
  • Both men and women can participate. Women who can become pregnant must use highly effective birth control methods with less than 1% failure rate. Men do not need to use birth control during the trial
  • Must have chronic kidney disease with specific kidney function measurements (eGFR) between 20 and 60 mL/min/1.73m2, confirmed by two tests:
    • One test from within the past year
    • One test at the first study visit
    • Must be taking a stable dose of either:
      • ACEi (a type of blood pressure medication that helps protect kidneys) or
      • ARB (another type of blood pressure medication that helps protect kidneys)
      • Must have been on this medication for at least 4 weeks before the first visit
      • Must not be taking both types of medications together
      • Must not plan to change this medication during the trial

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnancy or breastfeeding women
  • History of severe allergic reactions to medications
  • Participation in other clinical trials within the last 30 days
  • Severe liver problems (as measured by liver function tests)
  • Uncontrolled diabetes (blood sugar levels significantly above normal)
  • History of heart attack or stroke in the past 6 months
  • Severe kidney disease requiring dialysis
  • Active infections requiring treatment
  • Blood pressure that is not adequately controlled with medication
  • Major surgery planned during the study period
  • Substance abuse or alcohol dependency within the past year
  • Mental health conditions that could interfere with study participation
  • Use of medications that could interact with study drugs
  • Any condition that, in the investigator's opinion, could make participation unsafe
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Investigated drugs

Vicadrostat is an investigational medication being studied for treating chronic kidney disease. It is being tested to see how it affects kidney function when used in combination with another medication. Empagliflozin is a medication that helps lower blood sugar levels and has been shown to have beneficial effects on kidney function. It belongs to a class of medications called SGLT2 inhibitors, which work by helping the kidneys remove excess sugar from the blood through urination. This medication is already approved for use in patients with type 2 diabetes and certain heart and kidney conditions. The trial is studying whether it's better to start both medications at the same time or to start them one after another (staggered approach) in people with chronic kidney disease who are at risk of their condition getting worse.

What is already known about the treatment

  • Vicadrostat

    A novel investigational medication administered orally that is currently being studied in Phase II clinical trials for treating chronic kidney disease. It works by targeting specific molecular pathways involved in kidney function and is being evaluated in combination with empagliflozin to assess its potential in slowing kidney disease progression. The medication is being tested in a controlled clinical setting to determine its safety profile and effectiveness in improving estimated glomerular filtration rate (eGFR), which is a key indicator of kidney function.

  • Empagliflozin

    An oral medication belonging to the class of SGLT2 inhibitors that works by reducing blood sugar levels through increased glucose excretion in urine. It is already approved for treating type 2 diabetes and has shown significant benefits in protecting kidney function in patients with chronic kidney disease. The medication works by blocking glucose reabsorption in the kidneys, which not only helps control blood sugar but also provides protective effects on kidney function through various mechanisms including reduced inflammation and oxidative stress.

Investigated diseases

Chronic Kidney Disease - A long-term condition where the kidneys gradually lose their ability to filter waste and excess fluid from the blood. The disease typically develops over many years as the tiny filtering units in the kidneys become damaged. This condition often progresses silently in its early stages, with symptoms becoming more noticeable as kidney function declines. It can affect various bodily functions, including blood pressure regulation and red blood cell production. The disease may cause fluid retention, changes in urination patterns, and alterations in blood chemistry.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518457-42-00Protocol code1378-0023Estimated enrolment416 patientsSponsorBoehringer Ingelheim Espana S.A.

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