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New drug combo aims to slow kidney failure in High-Risk patients

NCT ID NCT07624305

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether a combination of two drugs (balcinrenone and dapagliflozin) works better than dapagliflozin alone for people with advanced chronic kidney disease (stages 3b and 4). About 2,800 participants will take the combination or a placebo daily, alongside standard care. The goal is to see if the combo can delay kidney failure, reduce heart-related deaths, and prevent hospitalizations for heart failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Balcinrenone and dapagliflozin combination pill
What this could lead to
If successful, this combination could offer a new treatment option to slow kidney disease progression and reduce heart complications in patients with advanced chronic kidney disease.
What could go wrong
This is a large phase 3 trial, but it hasn't started yet. The benefits over existing treatment may be modest, and there are risks like high potassium levels or side effects from the new drug combination.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,800 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years * Diagnosis of CKD and at least one of the following: 1. eGFR ≥ 15 to \< 45 mL/min/1.73 m2 AND: UACR ≥ 30 mg/g (central laboratory) or UACR ≥ 100 mg/g (local laboratory ) or UPCR ≥ 200 mg/g (local laboratory). 2. eGFR ≥ 15 to \< 30 mL/min/1.73 m2 and UACR \< 30 mg/g (local or central laboratory UACR value). * Serum/plasma K+ ≤ 5.0 mmol/L * Maximum tolerated dose of an ACEi or an ARB, unless contraindicated or not tolerated. The dose should be stable for at least 4 weeks before screening. Exclusion Criteria: * Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation * UACR ≥ 5000 mg/g or UPCR ≥ 7000 mg/g at screening. * SBP \> 180 mmHg or DBP \> 110 mmHg at screening. * SBP \< 90 mmHg at screening. * HbA1c \> 9% at screening * T1DM, except: 1. For US only: patients with T1DM treated with SGLT2i for at least 4 months prior to screening, without DKA during that period, and who have experience with ketone monitoring are eligible. 2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months prior to Screening, without DKA during the period of dapagliflozin treatment are eligible for inclusion. * Autosomal dominant polycystic kidney disease. * Major cardiac or valvular surgery, acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to screening. * Severe hepatic impairment (Child-Pugh Class C). * Adrenal insufficiency. * Clinically significant acute kidney injury within 12 weeks prior to the screening. * New York Heart Association functional HF class IV at screening, or hospitalisation for heart failure within 4 weeks prior to screening. * Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months) prior to screening. * Solid organ or bone marrow transplant or a plan for transplant within 6 months following randomisation. * Any use of the following medications and supplements: 1. MRAs 2. Aldosterone analogues 3. Aldosterone synthase inhibitors 4. Any use of potassium binders within 2 weeks prior to screening. Use is allowed after randomisation. 5. Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Renal insufficiency, chronic

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    45 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Research Site

    Ciudad de Buenos Aires, C1425AGC, Argentina

  • Research Site

    Edmonton, Alberta, T6G 2P4, Canada

  • Research Site

    Winnipeg, Manitoba, R2V 3M3, Canada

  • Research Site

    London, Ontario, N6A 5A5, Canada

  • Research Site

    Toronto, Ontario, M4G 3E8, Canada

  • Research Site

    Waterloo, Ontario, N2T 0C1, Canada

  • Research Site

    Halifax, NS B3H 2Y9, Canada

  • Research Site

    Magdeburg, 39120, Germany

  • Research Site

    Kita-ku, 144-0001, Japan

  • Research Site

    Osaka, 553-0003, Japan

  • Research Site

    Olsztyn, 10-561, Poland

  • Research Site

    Warsaw, 02-507, Poland

  • Research Site

    Warsaw, 04-141, Poland

  • Research Site

    Węgrów, 07-100, Poland

  • Research Site

    Wroclaw, 50-981, Poland

  • Research Site

    Żywiec, 34-300, Poland

  • Research Site

    Anyang, 14068, South Korea

  • Research Site

    Cheonan-si, 31151, South Korea

  • Research Site

    Seoul, 03181, South Korea

  • Research Site

    Seoul, 03312, South Korea

  • Research Site

    Seoul, 04401, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 08308, South Korea

  • Research Site

    Changhua, 500, Taiwan

  • Research Site

    Hualien City, 970473, Taiwan

  • Research Site

    Kaohsiung City, 813, Taiwan

  • Research Site

    Kaohsiung City, 833, Taiwan

  • Research Site

    New Taipei City, 220216, Taiwan

  • Research Site

    Taichung, 40201, Taiwan

  • Research Site

    Taichung, 404, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Taichung, 433004, Taiwan

  • Research Site

    Tainan, 70403, Taiwan

  • Research Site

    Tainan, 710, Taiwan

  • Research Site

    Taipei, 100, Taiwan

  • Research Site

    Taipei, 110, Taiwan

  • Research Site

    Taipei, 116, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Zhubei, 302, Taiwan

  • Research Site

    Da Nang, 55000, Vietnam

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Hanoi, 10000, Vietnam

  • Research Site

    Hà Nội, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Hochiminh City, 700000, Vietnam

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