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The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR or more 15 to < 45 mL/min/1.73 m2) administered orally once daily in addition to SoC.
This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials. (BalanceD-CKD)

A Phase III, Randomised, Double-blind, Study to Evaluate the Effect of Balcinrenone/Dapagliflozin Compared With Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Chronic Kidney Disease (Stage 3b and 4)

Tsugumi Hirotaka

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

RD-clinical-information-Japan@astrazeneca.com

Tsugumi Hirotaka

Astrazeneka K.K

3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka

+81-6-4802-3600

RD-clinical-information-Japan@astrazeneca.com

Recruiting

Sept. 01, 2026

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

1. Age 18 years or more

2. Diagnosis of CKD and at least one of the following:

a. eGFR 15 or more to less than 45 mL/min/1.73 m2 AND: UACR 30 mg/g or more (central laboratory) or UACR 100 mg/g or more (local laboratory) or UPCR 200 mg/g or more (local laboratory).

b. eGFR 15 or more to less than 30 mL/min/1.73 m2 and UACR less than 30 mg/g (local or central laboratory UACR value).

3. Serum/plasma K+ 5.0 mmol/L or less

4. 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.

1. Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation

2. UACR 5000 mg/g or more or UPCR 7000 mg/g or more at screening.

3. SBP more than 180 mmHg or DBP more than 110 mmHg at screening.

4. SBP less than 90 mmHg at screening.

5. HbA1c more than 9% at screening

6. T1DM (except: 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.)

7. Autosomal dominant polycystic kidney disease.

8. Major cardiac or valvular surgery, acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to screening.

9. Severe hepatic impairment (Child-Pugh Class C).

10. Adrenal insufficiency.

11. Clinically significant acute kidney injury within 12 weeks prior to the screening.

12. New York Heart Association functional HF class IV at screening, or hospitalisation for heart failure within 4 weeks prior to screening.

13. Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 m
onths) prior to screening.

14. Solid organ or bone marrow transplant or a plan for transplant within 6 months following randomisation.

15. Any use of the following medications and supplements: MRAs, Aldosterone analogues, Aldosterone synthase inhibitors, any use of potassium binders within 2 weeks prior to screening, strong or moderate inducers or inhibitors of CYP3A4 prohibited at least one week prior to randomisation

Both

Renal Insufficiency, Chronic

- Experimental: Balcinrenone/dapagliflozin
Patient receives once daily 1 capsule balcinrenone 15 mg and dapagliflozin 10 mg and 1 placebo tablet matching dapagliflozin.
Drug: Balcinrenone/dapagliflozin
balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg

- Active Comparator: Dapagliflozin
Patient receives once daily 1 placebo capsule matching balcinrenone and dapagliflozin and 1 tablet dapagliflozin 10 mg.
Drug: Dapagliflozin
dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

Time from randomization to first occurrence of cardiovascular death, death from kidney failure, kidney failure, sustained 50% or greater decline in eGFR, and heart failure event
Measure Description:
Time to first occurrence of any of the components of the composite:

- CV death
- Death from kidney failure
- Onset of kidney failure
- Initiation of maintenance dialysis or
- Kidney transplantation
- Sustained >_ 50% decline from baseline in eGFR
- HF with or without hospitalisation
[Time Frame]Up to 46 months.

+81-48-773-1111

July. 09, 2026

No

Researchers may see summary results, but they will not be able to see individual participant data or any personal identifiers.

Argentina/Austria/Brazil/Bulgaria/Canada/China/France/Germany/Greece/India/Italy/Malaysia/Mexico/Peru/Philippines/Poland/Romania/Saudi Arabia/South Korea/Spain/Taiwan/Thailand/Turkey/Ukraine/United Kingdom/United States of America/Vietnam