A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)

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