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Study on Balcinrenone and Dapagliflozin for Adults with Chronic Kidney Disease and Albuminuria

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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 the effects of a new treatment for Chronic Kidney Disease (CKD) with a condition called albuminuria, which is when a protein called albumin is found in the urine. The study will test a combination of two medications, Balcinrenone and Dapagliflozin, to see how well they work together compared to using Dapagliflozin alone. Dapagliflozin is already used to treat CKD, and this study aims to find out if adding Balcinrenone can improve treatment outcomes.

The purpose of the study is to determine if the combination of Balcinrenone and Dapagliflozin is more effective in reducing the amount of albumin in the urine than Dapagliflozin alone. Participants in the study will be randomly assigned to receive either the combination treatment or Dapagliflozin by itself. The study will last for about 12 weeks, during which time participants will take the medication orally, meaning by mouth, in the form of tablets or capsules.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The main focus will be on the change in the level of albumin in the urine from the start of the study to the end of the 12 weeks. This will help researchers understand the potential benefits and safety of the combination treatment for people with Chronic Kidney Disease and albuminuria.

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, kidney function, and current treatment. This ensures that the study is suitable for your condition.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes evaluating kidney function and levels of albumin in the urine.

  3. Step 3

    Medication administration

    You will receive either balcinrenone in combination with dapagliflozin or dapagliflozin alone. Both medications are taken orally.

    The specific dosage and frequency will be determined by the study protocol and communicated to you by the study team.

  4. Step 4

    Ongoing monitoring

    Regular monitoring is conducted to assess the effectiveness and safety of the treatment. This includes periodic checks of kidney function and albumin levels in the urine.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment is conducted to evaluate the overall impact of the treatment on your condition.

Who can join the trial?

6 criteria

  • Must be **18 years old** or older.
  • Must have a diagnosis of **Chronic Kidney Disease (CKD)**. This means the kidneys are not working as well as they should.
  • Must have an **eGFR** between 25 and less than 60 mL/min/1.73 m². **eGFR** is a test that measures how well the kidneys are filtering blood.
  • Must have a **UACR** greater than 100 mg/g and less than or equal to 5000 mg/g. **UACR** is a test that checks for a protein called albumin in the urine, which can indicate kidney problems.
  • Must have **serum potassium** levels between 3.5 mmol/L and 5.0 mmol/L. **Serum potassium** is a measure of the amount of potassium in the blood, which is important for heart and muscle function.
  • Must have been on a stable treatment with **RAAS inhibitors** for 4 weeks before the study. **RAAS inhibitors** are medications that help control blood pressure and protect the kidneys. If you cannot tolerate or are not treated with these medications, you can still participate.

Who cannot join the trial?

5 criteria

  • Patients who have a different condition than Chronic Kidney Disease with Albuminuria cannot participate. Albuminuria means having too much of a protein called albumin in the urine.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are not male or female cannot participate.
  • Patients who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups who might need special protection or care.
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Investigated drugs

  • Balcinrenone

    is a medication being studied to see if it can help reduce the amount of protein in the urine of patients with chronic kidney disease. It is being tested to find out if it works better when used together with another medication called dapagliflozin.

  • Dapagliflozin

    is a medication that is already used to help treat chronic kidney disease. It works by helping the kidneys remove extra sugar from the body through urine. In this study, it is being used to see how well it works with balcinrenone to reduce protein in the urine.

What is already known about the treatment

  • Balcinrenone

    This medication is administered orally and is currently being studied in clinical trials for its potential benefits in treating chronic kidney disease and albuminuria. It is not yet widely used in medical practice, as it is still under investigation. The main therapeutic indication for balcinrenone is to reduce albuminuria in patients with chronic kidney disease. At the molecular level, balcinrenone works by blocking certain receptors in the kidneys, which helps to decrease inflammation and protein leakage. It is classified pharmacologically as a mineralocorticoid receptor antagonist.

  • Dapagliflozin

    This medication is taken orally and is already approved for use in treating conditions like type 2 diabetes and heart failure. In the context of the clinical trial, it is being evaluated for its effectiveness in combination with balcinrenone for chronic kidney disease and albuminuria. Dapagliflozin works by inhibiting a protein in the kidneys that reabsorbs glucose, leading to increased glucose excretion in urine and improved kidney function. It belongs to the class of medications known as SGLT2 inhibitors.

Investigated diseases

  • Chronic Kidney Disease

    This condition involves the 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, symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns may occur. The progression can vary, with some individuals experiencing a slow decline in kidney function, while others may have a more rapid deterioration. Chronic kidney disease can eventually lead to kidney failure if not managed properly.

  • Albuminuria

    This condition is characterized by the presence of an abnormal amount of albumin, a type of protein, in the urine. It often indicates that the kidneys are not functioning properly, as healthy kidneys typically prevent significant amounts of protein from entering the urine. Albuminuria can be an early sign of kidney disease and may progress alongside other kidney-related conditions. It is often associated with conditions like diabetes and hypertension, which can further impact kidney health. Monitoring and managing albuminuria is important to prevent further kidney damage.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509709-63-00Protocol codeD6405C00002Estimated enrolment300 patientsSponsorAstraZeneca AB

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