Balcinrenone plus dapagliflozin vs dapagliflozin alone in CKD stages 3b-4

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, multicenter, randomized trial compares balcinrenone/dapagliflozin to dapagliflozin in adults with CKD stage 3b or 4 on standard care. It is double-blind and double-dummy, measuring cardiovascular and kidney outcomes as well as safety. Participants receive either the fixed combination capsule with a dapagliflozin placebo or dapagliflozin with a balcinrenone placebo daily for an extended, event-driven period across about 550 sites in ~30 countries. The study targets reductions in cardiovascular death, kidney failure, sustained eGFR decline, and heart failure events. Safety and tolerability of the combination will also be assessed.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  Surprise, Arizona, United States Recruiting
• Research Site
  Concord, California, United States Recruiting
• Research Site
  Riverview, Florida, United States Recruiting
• Research Site
  Savannah, Georgia, United States Recruiting
• Research Site
  Louisville, Kentucky, United States Recruiting
• Research Site
  Charlotte, North Carolina, United States Recruiting

+428 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: +18772409479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Clazakizumab for adults with high hsCRP at risk for a heart event

  This study tests whether clazakizumab can lower inflammation and reduce cardiovascular risk in adults with high hsCRP and existing risk factors.

  Recruiting at 32 sites Phase 2 Eli Lilly and Company · Huntsville, Alabama and 45 other locations · NCT07783802

• Living with CKD as a woman of childbearing age without dialysis or transplant

  This study asks how women aged 18 and up with chronic kidney disease, not on kidney replacement therapy, experience living with the condition.

  Recruiting University Hospital, Caen · Caen · NCT07690202

• Exercise during hemodialysis to prevent muscle loss and improve sleep

  This trial will test if a 12-week supervised exercise program performed during dialysis can improve muscle mass, strength, physical performance, sleep quality, and quality of life for patients aged 40 and over on chronic hemodialysis.

  Recruiting University of Salamanca · Salamanca, Salamanca · NCT07447375

• Home-based exercise to boost fitness for people waiting for a kidney transplant

  This study tests whether a 12-week, home-based exercise program plus a wearable activity tracker helps adults on the kidney transplant waiting list increase daily activity and improve physical function.

  Recruiting University of Pennsylvania · Philadelphia, Pennsylvania · NCT07446296

• Transformative 2.0 for diabetic kidney disease

  This project will try to see if adults with diabetic kidney disease who take SGLT2 diabetes medicines have different biological patterns in archived kidney tissue than similar people who do not take these medicines.

  Recruiting University of Pennsylvania · Philadelphia, Pennsylvania · NCT07444203

• Anrikefen vs Nalfurafine for sleep quality in kidney disease patients with itching

  A randomized, open-label study tests whether the injectable Anrikefen improves sleep better than the oral nalfurafine in adults on hemodialysis with CKD-associated itching.

  Recruiting Phase 4 Zhujiang Hospital · Guangzhou, Guangdong · NCT07380113

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.