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Phase III Randomized Study of Balcinrenone and Dapagliflozin Versus Dapagliflozin on Renal and Cardiovascular Outcomes in Patients with Chronic Kidney Disease Stage 3b‑4

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What is this trial about?

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

The study focuses on people with Chronic Kidney Disease stage 3b and 4, a condition where the kidneys are no longer able to filter waste as well as they should. The trial tests a new combination pill that contains balcinrenone and dapagliflozin. For comparison, another group receives only dapagliflozin and a third group receives a matching placebo that looks the same but does not contain active medicine.

The main purpose is to find out whether the combination pill can lower the chance of serious problems such as cardiovascular death, kidney failure, a large drop in eGFR (a blood test that shows how well the kidneys are working), or episodes of heart failure compared with the single‑drug pill.

Participants are randomly assigned to one of the three groups and take the study tablets by mouth every day. They will have regular visits where simple tests, like blood work and urine checks, are done to monitor kidney health and any side effects. The study follows each person for several years to record any of the listed health events.

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

    Randomization and Start of Study Medication

    After joining the study, you will be randomly assigned to receive either the test medication (a hard capsule containing balcinrenone and dapagliflozin) or the comparator medication (a film‑coated tablet of dapagliflozin 10 mg).

    The assignment is done by a computer system, so you will not know which treatment you receive.

  2. Step 2

    Baseline Assessments

    Before taking the first dose, basic health measurements will be recorded, including kidney function (estimated glomerular filtration rate, eGFR), blood pressure, and any existing heart conditions.

    These measurements provide a reference point for later comparisons.

  3. Step 3

    Daily Oral Medication

    You will take the assigned study medication by mouth once each day.

    If you receive the comparator, the tablet contains 10 mg of dapagliflozin. If you receive the test medication, the capsule contains a fixed combination of balcinrenone and dapagliflozin as defined by the study protocol.

    The exact amount of each active substance in the capsule is determined by the trial design and will be provided on the medication label.

  4. Step 4

    Routine Follow‑Up Visits

    You will attend scheduled clinic visits where your health will be checked and study data will be collected.

    At the visit that occurs around Week 24, a urine sample will be taken to measure the urinary albumin‑to‑creatinine ratio, which helps evaluate kidney health.

  5. Step 5

    Ongoing Monitoring for Clinical Events

    Throughout the study, you will be monitored for serious outcomes such as cardiovascular death, death from kidney failure, the onset of kidney failure (need for dialysis or kidney transplant), a sustained decline of 50 % or more in eGFR, and any heart failure events.

    If any of these events occur, they will be recorded as part of the study’s primary outcome.

  6. Step 6

    Final Study Assessment

    At the end of the study period, a final set of evaluations will be performed, including repeat measurements of kidney function, heart health, and any other data needed to compare the two treatment groups.

    The results will be used to determine whether the combination of balcinrenone and dapagliflozin provides additional benefit over dapagliflozin alone.

Who can join the trial?

7 criteria

  • You must be at least 18 years old.
  • You need to have chronic kidney disease (CKD) and meet one of these lab requirements:
    • Your eGFR (a test that estimates kidney filtering ability) must be between 15 and less than 45 mL/min/1.73 m², and you must have either:
      • UACR (a urine test that measures protein loss) of 30 mg/g or higher (measured in a central lab), or
      • UACR of 100 mg/g or higher (measured locally), or
      • UPCR (another urine protein test) of 200 mg/g or higher (measured locally).
      • Or, your eGFR must be between 15 and less than 30 mL/min/1.73 m², and your UACR must be less than 30 mg/g (measured locally or centrally).
      • Your blood potassium level (K⁺) must be 5.0 mmol/L or lower.
      • You must be taking the highest dose you can tolerate of an ACE inhibitor (ACEi) or an angiotensin receptor blocker (ARB)—both are medicines that help protect the kidneys—unless you cannot use them. This dose must have been stable for at least 4 weeks before the screening visit.

Who cannot join the trial?

18 criteria

  • Dialysis within the past 90 days, currently on dialysis, or likely to need dialysis within three months after starting the study – dialysis is a machine that cleans the blood when kidneys cannot.
  • Adrenal insufficiency – a condition where the adrenal glands do not make enough hormones.
  • A serious acute kidney injury within the last 12 weeks – a sudden loss of kidney function.
  • Severe heart failure (New York Heart Association class IV) at screening or a hospital stay for heart failure in the past four weeks – this means very serious symptoms even at rest.
  • Any disease that requires strong medicines that suppress the immune system, unless you have been on a stable low dose for at least three months.
  • A recent or planned solid‑organ or bone‑marrow transplant, or a transplant planned within six months after starting the study.
  • Use of certain drugs or supplements within the required time frames:
    • Mineralocorticoid receptor antagonists (MRAs)
    • Aldosterone analogues or aldosterone synthase inhibitors (medicines that affect a hormone called aldosterone)
    • Potassium binders (medicines that lower potassium levels) taken within two weeks before screening
    • Strong or moderate inducers or inhibitors of the enzyme CYP3A4 taken within one week before randomisation – these are medicines that can speed up or slow down how other drugs are processed.
    • Very high levels of protein in urine: UACR (urine albumin‑to‑creatinine ratio) ≥ 5000 mg/g or UPCR (urine protein‑to‑creatinine ratio) ≥ 7000 mg/g at screening.
    • Systolic blood pressure (the top number) higher than 180 mmHg or diastolic blood pressure (the bottom number) higher than 110 mmHg at screening – this is dangerously high blood pressure.
    • Systolic blood pressure lower than 90 mmHg at screening – this is dangerously low blood pressure.
    • Hemoglobin A1c (HbA1c) greater than 9% at screening – a lab test that shows average blood sugar over the past three months.
    • Having type 1 diabetes (unless you meet very specific exceptions not listed here).
    • Having autosomal dominant polycystic kidney disease – a genetic condition that causes many cysts to form in the kidneys.
    • Major heart or valve surgery, a recent heart attack or unstable chest pain (acute coronary syndrome), stroke, or a mini‑stroke (transient ischemic attack) within the past 12 weeks.
    • Severe liver disease classified as Child‑Pugh Class C – the most serious level of liver impairment.
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Investigated drugs

  • dapagliflozin

    is a pill taken by mouth that helps the kidneys get rid of extra sugar in the urine. By lowering blood sugar, it can also protect the kidneys and the heart. In this trial it is used as the standard treatment to see how well the new combination works compared with it.

  • balcinrenone/dapagliflozin

    is a combination therapy that contains two medicines in one capsule. The dapagliflozin part works as described above, helping the kidneys remove sugar and supporting kidney and heart health. The balcinrenone part is a new experimental drug being tested to see if it adds extra protection for the kidneys and reduces heart problems when used together with dapagliflozin. Participants take both medicines together in a single hard capsule.

What is already known about the treatment

  • Forxiga 10 mg film-coated tablets

    This medication is taken by mouth as a film‑coated tablet. It is an approved drug that is widely used and described in many medical studies. It is mainly prescribed for type 2 diabetes, heart failure, and chronic kidney disease. It works by blocking the protein SGLT2 in the kidneys, which makes the body remove extra sugar in the urine, helping lower blood sugar and reduce stress on the heart and kidneys. It belongs to the class of SGLT2 inhibitors, a type of glucose‑lowering medicine.

  • Balcinrenone+Dapagliflozin

    This product is taken by mouth as a hard capsule that contains two active ingredients. It is still investigational and is being studied in clinical trials for safety and benefit. It is being tested for chronic kidney disease, with the goal of improving kidney function and lowering heart‑related risks. Balcinrenone is a new agent that is thought to protect kidney cells and reduce harmful inflammation, while dapagliflozin works as described above by blocking SGLT2 to help the kidneys remove excess sugar. The combination is classified as an experimental dual‑therapy that includes an SGLT2 inhibitor and a novel renal‑protective compound.

Investigated diseases

  • Chronic kidney disease

    a condition where the kidneys gradually lose the ability to filter waste and fluid from the blood. It often begins with a mild reduction in function and can progress to more severe loss, leading to waste buildup and fluid overload. Over time the decline in kidney function is measured by eGFR, which may fall steadily over years. As the disease advances, patients may develop anemia, bone changes, and problems with the heart and blood vessels. In the final stages, dialysis or a kidney transplant may be required.

  • Heart failure

    a syndrome in which the heart cannot pump enough blood to meet the body’s needs. It may start with shortness of breath during activity and swelling in the ankles as the condition worsens. The heart muscle can become weaker or stiffer, causing fluid to collect in the lungs and other tissues. Periods of worsening symptoms, called decompensation, may need urgent medical care. The condition usually progresses slowly but can accelerate if other health issues develop.

  • Cardiovascular disease

    a group of disorders that affect the heart and blood vessels, including conditions such as coronary artery disease, stroke, and peripheral artery disease. These disorders develop as arteries become narrowed or blocked, reducing blood flow. Over time, reduced blood supply can cause chest pain, heart attacks, or tissue damage. The disease often progresses without obvious symptoms until an event occurs. Common risk factors include smoking, high blood pressure, high cholesterol, and diabetes.

Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526114-90-00Protocol codeD8790C00001Estimated enrolment2 438 patientsSponsorAstraZeneca AB

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