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

NCT07624305Sponsor: AstraZenecaPavel RoshanovPavel Roshanov

Actively Recruiting

View on ClinicalTrials.gov ↗

About This Study

This Phase III, randomised, double-blind, active-controlled study evaluates balcinrenone/dapagliflozin versus dapagliflozin, both added to standard-of-care therapy, in adults with stage 3b or 4 CKD (eGFR ≥15 to <45 mL/min/1.73 m²). Participants receive once-daily balcinrenone/dapagliflozin 15/10 mg or dapagliflozin 10 mg, with matching placebos. The study assesses renal and cardiovascular outcomes, including kidney failure, sustained ≥50% eGFR decline, CV death and HF events, as well as safety and tolerability.

Who Can Participate?

✓ Inclusion Criteria

  • •Age ≥ 18 years
  • •Diagnosis of CKD and at least one of the following:
  • •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).
  • •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:
  • •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.
  • •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:
  • •MRAs
  • •Aldosterone analogues
  • •Aldosterone synthase inhibitors
  • •Any use of potassium binders within 2 weeks prior to screening. Use is allowed after randomisation.
  • •Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation