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Study to Find Treatments for Chronic Kidney Disease Using Finerenone in Patients with Standard Care

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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 finding treatments to slow the progression of Chronic Kidney Disease (CKD). The study will investigate the effects of a medication called Kerendia, which contains the active substance finerenone. Kerendia is available in two forms: 10 mg and 20 mg film-coated tablets. The purpose of the study is to determine if Kerendia can reduce the rate of kidney function decline in patients with CKD, compared to a placebo.

Participants in the study will receive either Kerendia or a placebo, taken orally as a tablet. The study will last for a period of up to 24 months. During this time, participants will continue to receive their standard care for CKD. The study aims to observe changes in kidney function, specifically looking at the estimated glomerular filtration rate (eGFR), which is a measure of how well the kidneys are working. The study will also monitor other health outcomes, such as changes in protein levels in the urine and the occurrence of cardiovascular events like heart attacks or strokes.

The trial will help researchers understand if Kerendia can effectively slow down the progression of CKD and improve the quality of life for those affected by this condition. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on the medication's effects. The findings from this study could lead to better treatment options for people living with CKD.

The research process

The trial runs in 6 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, you will provide written informed consent or eConsent. This is a document that confirms your willingness to participate and that you understand the study procedures.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes checking your age, medical history of chronic kidney disease, and current treatment regimen.

    Your urine will be tested to measure the albumin-creatinine ratio (uACR) or protein-creatinine ratio (uPCR) to ensure it meets the study requirements.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either the investigational medication finerenone or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.

    The dosage of finerenone will be either 10 mg or 20 mg, taken orally as a film-coated tablet.

  4. Step 4

    Treatment phase

    You will take the assigned tablet once daily for the duration of the study.

    Regular check-ups will be scheduled to monitor your health and the progression of your kidney function. This includes measuring your estimated glomerular filtration rate (eGFR), which indicates how well your kidneys are working.

  5. Step 5

    Follow-up assessments

    Throughout the study, your kidney function and overall health will be assessed at regular intervals, up to 108 weeks.

    Your quality of life will be evaluated using a survey designed for individuals with kidney disease.

  6. Step 6

    End of study

    At the end of the study period, a final assessment will be conducted to evaluate the effects of the treatment on your kidney function and overall health.

    The study aims to determine if the investigational medication can slow the progression of chronic kidney disease compared to the placebo.

Who can join the trial?

9 criteria

  • Must be 18 years or older.
  • Must have chronic kidney disease from any cause, with a kidney function test result (eGFR) of 25 or more.
  • Must qualify for random selection in at least one specific part of the study.
  • Must have a recent urine test showing a high level of protein in the urine, either with a urine albumin-creatinine ratio (uACR) of more than 200 mg/g or a urine protein-creatinine ratio (uPCR) of more than 300 mg/g.
  • Must be on a stable treatment plan for chronic kidney disease, including a type of medication called SGLT2 inhibitor (unless there is a documented reason not to use it), for at least 4 weeks before the study starts.
  • The doctor must believe that a medication called finerenone is suitable for the participant.
  • Must currently be receiving standard treatment for chronic kidney disease as per the doctor's advice.
  • Both the participant and the doctor must be willing and able to carry out the main procedures of the study.
  • Must provide written informed consent or electronic consent before starting any study-related procedures.

Who cannot join the trial?

9 criteria

  • Patients with any other serious medical condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a kidney transplant.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of allergic reactions to the study medication.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver disease.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures.
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Investigated drugs

CAPTIVATE-001 is a medication being tested in this trial. It is designed to help slow down the progression of chronic kidney disease. This medication works by targeting specific pathways in the body that are involved in kidney function. By doing so, it aims to reduce the rate at which the kidneys lose their ability to filter waste from the blood, which is a common problem in chronic kidney disease. The goal is to help maintain kidney health for a longer period, potentially improving the quality of life for patients with this condition.

What is already known about the treatment

I'm sorry, but the provided data does not include the trade name or specific details about any medication involved in the clinical trial. If you can provide the trade name or more specific information about the medication, I would be able to create a description for you.

Investigated diseases

Chronic Kidney Disease – Chronic Kidney Disease is a long-term condition characterized by a gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. As the disease progresses, patients may experience symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. The progression of the disease can lead to more severe complications, including high blood pressure, anemia, and bone disease. In advanced stages, the kidneys may fail to function adequately, necessitating dialysis or a kidney transplant. The rate of progression can vary among individuals, influenced by factors such as underlying health conditions and lifestyle choices.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520253-21-00Protocol codeP01351Estimated enrolment1 100 patientsSponsorThe George Institute For Global Health

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