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

NCT07624305
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Phase
Phase 3
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Recruitment status
Not yet recruiting
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Participants
2,800
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Lead sponsor
AstraZeneca
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Start date
2026-09-01
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Number of sites
45
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Summary
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.
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Short title
A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
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Official title
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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-07-01
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First posted
2026-06-03
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Registry last updated
2026-06-03
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Primary completion date
2030-07-01
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Start date
2026-09-01
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Participants
2,800
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Participant count basis
Estimated
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Planned participants
2,800
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Protocol amendments
0
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Randomisation ratio
1:1
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Number of sites
45
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07624305
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ClinicalTrials.gov ID
NCT07624305
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Double-blind study.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. 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

    Timeframe: Up to 46 months.

    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

  1. Time from randomization to first occurrence of cardiovascular death, death from kidney failure, kidney failure and sustained 50% or greater decline in eGFR.

    Timeframe: Up to 46 months.

    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

  2. Change from baseline in urinary albumin to creatinine ratio to Week 24

    Timeframe: Baseline to Week 24

    Change from baseline to Week 24 in urinary albumin to creatinine ratio, assessed from spot urine albumin and creatinine measurements

  3. Time from randomization to first occurrence of cardiovascular death or heart failure event.

    Timeframe: Up to 46 months.

    Time to first occurrence of any of the components of the composite: * CV death * HF with or without hospitalisation

  4. Time from randomization to cardiovascular death

    Timeframe: Up to 46 months.

    Time from randomization to cardiovascular death.

  5. Time from randomization to death from any cause

    Timeframe: Up to 46 months.

    Time from randomization to death from any cause.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No

  • 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.

  • 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
Sources for eligibility
clinicaltrials.gov

  • Research SiteCiudad de Buenos Aires, Argentina
  • Research SiteEdmonton, Canada
  • Research SiteWinnipeg, Canada
  • Research SiteLondon, Canada
  • Research SiteToronto, Canada
  • Research SiteWaterloo, Canada
  • Research SiteHalifax, Canada
  • Research SiteMagdeburg, Germany
  • Research SiteKita-ku, Japan
  • Research SiteOsaka, Japan
  • Research SiteOlsztyn, Poland
  • Research SiteWarsaw, Poland
  • Research SiteWarsaw, Poland
  • Research SiteWęgrów, Poland
  • Research SiteWroclaw, Poland
  • Research SiteŻywiec, Poland
  • Research SiteAnyang, South Korea
  • Research SiteCheonan-si, South Korea
  • Research SiteSeoul, South Korea
  • Research SiteSeoul, South Korea
  • Research SiteSeoul, South Korea
  • Research SiteSeoul, South Korea
  • Research SiteSeoul, South Korea
  • Research SiteChanghua, Taiwan
  • Research SiteHualien City, Taiwan

And 20 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2026-526114-90-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)