NCT07624305 · AstraZeneca
A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
What this study is about
The purpose of this study is to evaluate the effectiveness, safety and how well patients handle the treatment 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 taken by mouth once daily in addition to SoC.
View original scientific description
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.
Interventions
DRUG
Balcinrenone/dapagliflozin
balcinrenone/dapagliflozin 15 mg/10 mg
DRUG
Dapagliflozin
dapagliflozin 10 mg
DRUG
Placebo matching Dapagliflozin
matching placebo for dapagliflozin 10 mg
DRUG
Placebo matching balcinrenone/dapagliflozin
matching placebo for balcinrenone/dapagliflozin
Primary outcome measures
Time 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.
Time from randomization 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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
Where
- Huntsville, Alabama
- Surprise, Arizona
- Tempe, Arizona
- Little Rock, Arkansas
- Concord, California
- Daly City, California
- Fremont, California
- Huntington Park, California
- Lancaster, California
- Lynwood, California
- Northridge, California
- Palo Alto, California
And 54 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2026 · Source of record for eligibility and locations