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Study on the Effectiveness and Safety of BAY 3283142 in Reducing Urine Albumin for Patients with Chronic Kidney Disease

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a condition known as chronic kidney disease, which affects the kidneys' ability to filter waste from the blood. The trial will evaluate a new treatment called BAY 3283142, which is taken as a coated tablet. The purpose of the study is to learn how well this new drug works and how safe it is in reducing the amount of a protein called albumin in the urine of people with chronic kidney disease. Albumin in the urine is a sign that the kidneys are not working as well as they should.

Participants in the study will be randomly assigned to receive either the new drug BAY 3283142 or a placebo, in addition to their standard care. The study will last for 16 weeks, during which time the participants will take the medication orally. The researchers will monitor changes in the urine albumin-creatinine ratio, which is a measure used to assess kidney function. This will help determine the most effective dose of the new drug for future studies.

Throughout the study, participants will have regular check-ups to monitor their kidney function and overall health. The study aims to find the best dose of BAY 3283142 to help reduce albumin in the urine, which could potentially improve kidney health in people with chronic kidney disease. The results of this study will help guide further research and development of this treatment.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age and kidney function.

    Participants must be 18 years or older and have a specific range of kidney function as measured by eGFR, a test that estimates how well the kidneys are filtering.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements, including urine tests to determine the albumin-creatinine ratio (UACR).

    Participants must have a stable dose of certain medications for at least four weeks before this assessment.

  3. Step 3

    Treatment phase

    Participants receive either the new drug BAY 3283142 or a placebo, both in the form of coated tablets taken orally.

    The treatment lasts for 16 weeks, during which the effect on urine albumin levels is monitored.

  4. Step 4

    Monitoring visits

    Regular visits are scheduled to monitor kidney function and any changes in the urine albumin-creatinine ratio.

    These visits occur at specific intervals, referred to as Visits 5, 6, and 7, to track progress and any side effects.

  5. Step 5

    End of treatment evaluation

    At the end of the 16-week treatment period, a final evaluation is conducted to assess changes in kidney function and urine albumin levels.

    The primary goal is to determine the effectiveness and safety of the new drug compared to the placebo.

Who can join the trial?

5 criteria

  • Participant must be at least 18 years old.
  • **eGFR** (a test that measures how well your kidneys are working) should be between 20 and 75 mL/min/1.73 m² at the time of screening. If needed, this test can be done again during the screening period.
  • **UACR** (a test that checks the amount of protein in your urine) should be between 200 mg/g and less than 3500 mg/g, based on the average of three morning urine samples taken during screening.
  • Participant should be on the highest tolerated dose of either **ACEI** (a type of medication that helps relax blood vessels) or **ARB** (another type of medication that helps relax blood vessels), unless they cannot tolerate it or it is not suitable for them. The dose should be stable for at least 4 weeks before screening, with no planned changes during the study.
  • If the participant is taking any of the following treatments, they should be stable for 4 weeks before screening: **SGLT2 inhibitor** (a medication that helps lower blood sugar), **finerenone** (a medication used for kidney and heart protection), **diuretics** (medications that help remove excess fluid from the body), **endothelin-receptor antagonists** (medications that help relax blood vessels), or **GLP receptor agonist** (medications that help control blood sugar).

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent heart attack or stroke.
  • Patients with severe liver disease.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have an allergy to the study medication.
  • Patients who have had a kidney transplant.
  • Patients with uncontrolled high blood pressure.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

BAY 3283142 is an investigational medication being studied for its potential to reduce albuminuria in patients with chronic kidney disease. Albuminuria is a condition where there is an excess amount of protein called albumin in the urine, which can be a sign of kidney damage. This medication is being tested to see how well it can lower the levels of albumin in the urine when used alongside standard treatments for chronic kidney disease. The study aims to find the most effective dose of this medication for future research.

What is already known about the treatment

BAY 3283142 – This medication is administered orally and is currently being studied in clinical trials for its potential to treat chronic kidney disease. It is in the Phase 2b stage of clinical trials, where its efficacy and safety are being evaluated. The main therapeutic indication is to reduce albuminuria, which is a condition characterized by an excess of albumin in the urine, commonly associated with chronic kidney disease. At the molecular level, BAY 3283142 is believed to work by modulating pathways that affect kidney function, although the exact mechanism is still under investigation. It is classified pharmacologically as a potential treatment for kidney-related conditions.

Investigated diseases

Chronic kidney disease – Chronic kidney disease is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This disease progresses over time, often without noticeable symptoms in the early stages. As kidney function declines, waste products can build up in the body, leading to symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. The progression of the disease can lead to complications like high blood pressure, anemia, and bone disease. In advanced stages, the kidneys may fail completely, requiring dialysis or a kidney transplant. The rate of progression can vary depending on the underlying cause and individual health factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505755-40-00Protocol code22040Estimated enrolment1 400 patientsSponsorBayer AG

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).