A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)
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)
- Renal Insufficiency, Chronic
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- AstraZeneca
- Enrolment target
- 2,800
- Started
- 1 September 2026
- Main results due
- 1 July 2030
- Study sites
- 478
- Registry updated
- 24 September 2026
Can you take part?
- Ages 18 years to 99 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(478)
Research Site
Huntsville, Alabama, United States
Not yet recruiting
Research Site
Surprise, Arizona, United States
Recruiting
Research Site
Tempe, Arizona, United States
Not yet recruiting
Research Site
Little Rock, Arkansas, United States
Not yet recruiting
Research Site
Concord, California, United States
Recruiting
Research Site
Daly City, California, United States
Not yet recruiting
Research Site
Fremont, California, United States
Not yet recruiting
Research Site
Huntington Park, California, United States
Not yet recruiting
Research Site
Lancaster, California, United States
Not yet recruiting
Research Site
Lynwood, California, United States
Not yet recruiting
Research Site
Northridge, California, United States
Not yet recruiting
Research Site
Palo Alto, California, United States
Not yet recruiting
Research Site
Pomona, California, United States
Not yet recruiting
Research Site
Riverside, California, United States
Not yet recruiting
Research Site
San Dimas, California, United States
Not yet recruiting
Research Site
Tarzana, California, United States
Not yet recruiting
Research Site
Washington D.C., District of Columbia, United States
Not yet recruiting
Research Site
Boca Raton, Florida, United States
Not yet recruiting
Research Site
Fort Lauderdale, Florida, United States
Not yet recruiting
Research Site
Gainesville, Florida, United States
Not yet recruiting
Research Site
Hollywood, Florida, United States
Not yet recruiting
Research Site
Jacksonville Beach, Florida, United States
Not yet recruiting
Research Site
Lakeland, Florida, United States
Not yet recruiting
Research Site
Melbourne, Florida, United States
Suspended
Research Site
Orlando, Florida, United States
Not yet recruiting
Research Site
Port Charlotte, Florida, United States
Not yet recruiting
Research Site
Riverview, Florida, United States
Recruiting
Research Site
Weston, Florida, United States
Not yet recruiting
Research Site
Brunswick, Georgia, United States
Not yet recruiting
Research Site
East Point, Georgia, United States
Not yet recruiting
Research Site
Macon, Georgia, United States
Not yet recruiting
Research Site
Savannah, Georgia, United States
Recruiting
Research Site
Oak Brook, Illinois, United States
Not yet recruiting
Research Site
Rockford, Illinois, United States
Not yet recruiting
Research Site
Iowa City, Iowa, United States
Not yet recruiting
Research Site
Wichita, Kansas, United States
Not yet recruiting
Research Site
Louisville, Kentucky, United States
Recruiting
Research Site
Ann Arbor, Michigan, United States
Not yet recruiting
Research Site
Saint Joseph, Michigan, United States
Not yet recruiting
Research Site
Mankato, Minnesota, United States
Not yet recruiting
Research Site
Kansas City, Missouri, United States
Not yet recruiting
Research Site
Albuquerque, New Mexico, United States
Not yet recruiting
Research Site
Albany, New York, United States
Not yet recruiting
Research Site
Long Island City, New York, United States
Not yet recruiting
Research Site
The Bronx, New York, United States
Not yet recruiting
Research Site
Asheville, North Carolina, United States
Not yet recruiting
Research Site
Charlotte, North Carolina, United States
Recruiting
Research Site
Cincinnati, Ohio, United States
Not yet recruiting
Research Site
Cincinnati, Ohio, United States
Not yet recruiting
Research Site
Media, Pennsylvania, United States
Not yet recruiting
Research Site
Columbia, South Carolina, United States
Not yet recruiting
Research Site
Greenville, South Carolina, United States
Not yet recruiting
Research Site
Chattanooga, Tennessee, United States
Not yet recruiting
Research Site
Fort Worth, Texas, United States
Recruiting
Research Site
Houston, Texas, United States
Not yet recruiting
Research Site
Irving, Texas, United States
Not yet recruiting
Research Site
Lufkin, Texas, United States
Not yet recruiting
Research Site
McKinney, Texas, United States
Not yet recruiting
Research Site
Pasadena, Texas, United States
Recruiting
Research Site
San Antonio, Texas, United States
Not yet recruiting
Showing 60 of 478 sites — filter to narrow it down. 33 of the 478 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07624305. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me