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New drug cocktail aims to slow kidney disease

NCT ID NCT06350123

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether adding balcinrenone to the standard drug dapagliflozin helps people with chronic kidney disease more than dapagliflozin alone. 324 adults with kidney disease and protein in their urine took either a combination pill or dapagliflozin alone for 12 weeks. Researchers measured changes in urine protein levels to see if the combo works better.

What this could mean

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

Active substance
balcinrenone combined with dapagliflozin
What this could lead to
If successful, this could lead to a more effective treatment option for chronic kidney disease by reducing protein in urine better than current standard therapy.
What could go wrong
This is an early dose-finding study (Phase IIb) with only 324 participants. The combination may not prove significantly better than dapagliflozin alone, and side effects or tolerability issues could emerge.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

324 people

The number who actually took part.

Started

May 2024

Finished

May 2025

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 years and older

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 old - Diagnosis of CKD and eGFR ≥ 25 to \< 60 mL/min/1.73 m2. - UACR \> 100 mg/g (10 mg/mmol) to ≤ 5000 mg/g (500 mg/mmol). - Serum potassium ≥ 3.5 mmol/L to ≤ 5.0 mmol/L. - Stable RAAS inhibitors treatment for 4 weeks before screening. Participants who cannot tolerate or are not treated with RAAS inhibitors can also participate in the study. Exclusion criteria: - Uncontrolled arterial hypertension (SBP \> 160 mmHg or DBP \> 100 mmHg). - Hypotension defined as SBP \< 100 mmHg. - Autosomal dominant polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis or other nephropathies that are unstable or progress rapidly. - Cytotoxic or immunomodulatory therapy within 6 months prior to screening, or current, or planned within 6 months following randomization. - History of solid organ or bone marrow transplantation - Recent (90 d prior to screening) or ongoing dialysis, or likely need for dialysis within 3 months following randomization. - Myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous 12 weeks. - Type 1 diabetes mellitus (DM) or uncontrolled type 2 DM. - Hepatic disease, including active hepatitis, and/or hepatic impairment (Child-Pugh class B-C; or any of AST or ALT \> 3 × ULN; or TBL \> 2 × ULN. - Serum HCO3 \< 18 mmol/L at screening. - Adrenal insufficiency (eg, Addison's disease, prolonged use of glucocorticoids). - Any use of the following within 4 weeks prior to screening: - MRA (or planned initiation of MRA treatment), potassium sparing diuretic, potassium binders, fludrocortisone. - Strong or moderate CYP3A4 inducers or inhibitors prohibited at least 1 week prior to randomisation and during treatment.

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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.

Chronic kidney disease

Contacts and locations

Locations

  • Research Site

    Sheffield, Alabama, 35660, United States

  • Research Site

    Glendale, California, 91206, United States

  • Research Site

    Waterbury, Connecticut, 06708, United States

  • Research Site

    Hialeah, Florida, 33012, United States

  • Research Site

    Miami Lakes, Florida, 33014, United States

  • Research Site

    Annapolis, Maryland, 21401, United States

  • Research Site

    New Bern, North Carolina, 28562, United States

  • Research Site

    El Paso, Texas, 79935, United States

  • Research Site

    Houston, Texas, 77079, United States

  • Research Site

    Houston, Texas, 77099, United States

  • Research Site

    San Antonio, Texas, 78212, United States

  • Research Site

    Ogden, Utah, 84405, United States

  • Research Site

    Salt Lake City, Utah, 84115, United States

  • Research Site

    Salt Lake City, Utah, 84124, United States

  • Research Site

    Norfolk, Virginia, 23504, United States

  • Research Site

    Linz, 4021, Austria

  • Research Site

    Sankt Pölten, 3100, Austria

  • Research Site

    Vienna, 1030, Austria

  • Research Site

    Vienna, 1130, Austria

  • Research Site

    Vienna, 1190, Austria

  • Research Site

    Vienna, A-1090, Austria

  • Research Site

    Wels, 4600, Austria

  • Research Site

    Porto Alegre, 90020-090, Brazil

  • Research Site

    São Paulo, 01228-000, Brazil

  • Research Site

    São Paulo, 04012-909, Brazil

  • Research Site

    São Paulo, 04038-031, Brazil

  • Research Site

    São Paulo, 05403-9000, Brazil

  • Research Site

    Burgas, 8018, Bulgaria

  • Research Site

    Dobrich, 9300, Bulgaria

  • Research Site

    Pleven, 5800, Bulgaria

  • Research Site

    Plovdiv, 4000, Bulgaria

  • Research Site

    Sofia, 1680, Bulgaria

  • Research Site

    London, Ontario, N6A 5A5, Canada

  • Research Site

    Waterloo, Ontario, N2T 0C1, Canada

  • Research Site

    Montreal, Quebec, H4J 1C5, Canada

  • Research Site

    Québec, Quebec, G1R 2J6, Canada

  • Research Site

    Changchun, 130021, China

  • Research Site

    Changzhou, 213004, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shanghai, 200050, China

  • Research Site

    Tianjin, 300050, China

  • Research Site

    Bari, 70124, Italy

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Genoa, 16132, Italy

  • Research Site

    Pavia, 27100, Italy

  • Research Site

    Ageo, 362-8588, Japan

  • Research Site

    Fujisawa-shi, 251-0041, Japan

  • Research Site

    Fukuoka, 810-8563, Japan

  • Research Site

    Koga-shi, 306-0232, Japan

  • Research Site

    Koshigaya-shi, 343-8577, Japan

  • Research Site

    Kumamoto, 860-0008, Japan

  • Research Site

    Nagasaki, 852-8034, Japan

  • Research Site

    Nagoya, 451-8511, Japan

  • Research Site

    Okinawa-shi, 904-2143, Japan

  • Research Site

    Takamatsu, 760-0076, Japan

  • Research Site

    Zentsuji-shi, 765-8507, Japan

  • Research Site

    Ipoh, 30990, Malaysia

  • Research Site

    Johor Bahru, 80100, Malaysia

  • Research Site

    Kajang, 43000, Malaysia

  • Research Site

    Kota Bharu, 15586, Malaysia

  • Research Site

    Kuala Terengganu, 20400, Malaysia

  • Research Site

    Bialystok, 15-481, Poland

  • Research Site

    Grodzisk Mazowiecki, 05-825, Poland

  • Research Site

    Leżajsk, 37-300, Poland

  • Research Site

    Szczecin, 70-111, Poland

  • Research Site

    Warsaw, 02-798, Poland

  • Research Site

    Żywiec, 34-300, Poland

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Córdoba, 14004, Spain

  • Research Site

    Palma de Mallorca, 07010, Spain

  • Research Site

    Valencia, 46026, Spain

  • Research Site

    Kaohsiung City, 80756, Taiwan

  • Research Site

    New Taipei City, 220, Taiwan

  • Research Site

    Taichung, 40201, Taiwan

  • Research Site

    Tainan, 710, Taiwan

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 110, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taipei, 11490, Taiwan

  • Research Site

    Ankara, 06340, Turkey (Türkiye)

  • Research Site

    Gaziantep, 27310, Turkey (Türkiye)

  • Research Site

    Kahramanmaraş, 46100, Turkey (Türkiye)

  • Research Site

    Kayseri, 38039, Turkey (Türkiye)

  • Research Site

    Kocaeli, 41380, Turkey (Türkiye)

  • Research Site

    Dundee, DDS 1SY, United Kingdom

  • Research Site

    London, N18 1QX, United Kingdom

  • Research Site

    Newquay, TR7 1RU, United Kingdom

  • Research Site

    Nottingham, NG9 6DX, United Kingdom

  • Research Site

    Haiphong, 180000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

  • Research Site

    Hochiminh City, 700000, Vietnam

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