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

Sponsor
AstraZeneca
Study ID
NCT07624305
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Renal Insufficiency, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Balcinrenone/dapagliflozin — DRUG
    balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
  • Dapagliflozin — DRUG
    dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

Study Details

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 ≥ 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.

Key Dates

Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Jul 1, 2030
Completion
Jul 1, 2030

Study Design

Enrollment
2,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Balcinrenone/dapagliflozin
    Patient receives once daily 1 capsule balcinrenone 15 mg and dapagliflozin 10 mg and 1 placebo tablet matching dapagliflozin.
  • Active Comparator: Dapagliflozin
    Patient receives once daily 1 placebo capsule matching balcinrenone and dapagliflozin and 1 tablet dapagliflozin 10 mg.

Primary Outcome Measure

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 [ Time Frame: Up to 46 months. ]

Central Contacts

Related Studies