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)

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 Overview

• Status: Not yet recruiting
• Conditions: Renal Insufficiency, Chronic
• Intervention / Treatment: Drug: Balcinrenone/dapagliflozin; Drug: Dapagliflozin

Detailed Description

This is a Phase III, multicentre, randomised, double-blind, double-dummy, parallel-group, active-controlled, event-driven study in participants with CKD Stage 3b and 4.

The purpose of this study is to determine if balcinrenone/dapagliflozin, compared with dapagliflozin, administered as a capsule once daily on a background of standard of care (SoC) therapy, reduces the risk of CV death, death from kidney failure, kidney failure, sustained ≥ 50% decline from baseline in eGFR, and HF events in adults with CKD Stage 3b and 4. The study will also assess safety and tolerability of balcinrenone/dapagliflozin.

Eligible patients will randomly be assigned with a 1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:

1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
2. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study will be conducted at approximately 550 sites in approximately 30 countries, globally.

• Study Type: Interventional
• Enrollment (Estimated): 2800
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: +18772409479; Email: information.center@astrazeneca.com
• Study Contact Backup: Name: AstraZeneca Clinical AstraZeneca Clinical; Phone Number: +18772409479; Email: information.center@astrazeneca.com

Study Locations

• Argentina
  • Ciudad de Buenos Aires, Argentina, C1425AGC
    • Research Site
• Canada
  • Halifax, Canada, NS B3H 2Y9
    • Research Site
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2P4
      • Research Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2V 3M3
      • Research Site
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Research Site
    • Toronto, Ontario, Canada, M4G 3E8
      • Research Site
    • Waterloo, Ontario, Canada, N2T 0C1
      • Research Site
• Germany
  • Magdeburg, Germany, 39120
    • Research Site
• Japan
  • Kita-ku, Japan, 144-0001
    • Research Site
  • Osaka, Japan, 553-0003
    • Research Site
• Poland
  • Olsztyn, Poland, 10-561
    • Research Site
  • Warsaw, Poland, 02-507
    • Research Site
  • Warsaw, Poland, 04-141
    • Research Site
  • Wroclaw, Poland, 50-981
    • Research Site
  • Węgrów, Poland, 07-100
    • Research Site
  • Żywiec, Poland, 34-300
    • Research Site
• South Korea
  • Anyang, South Korea, 14068
    • Research Site
  • Cheonan-si, South Korea, 31151
    • Research Site
  • Seoul, South Korea, 08308
    • Research Site
  • Seoul, South Korea, 06351
    • Research Site
  • Seoul, South Korea, 03312
    • Research Site
  • Seoul, South Korea, 03181
    • Research Site
  • Seoul, South Korea, 04401
    • Research Site
• Taiwan
  • Changhua, Taiwan, 500
    • Research Site
  • Hualien City, Taiwan, 970473
    • Research Site
  • Kaohsiung City, Taiwan, 813
    • Research Site
  • Kaohsiung City, Taiwan, 833
    • Research Site
  • New Taipei City, Taiwan, 220216
    • Research Site
  • Taichung, Taiwan, 40705
    • Research Site
  • Taichung, Taiwan, 40201
    • Research Site
  • Taichung, Taiwan, 404
    • Research Site
  • Taichung, Taiwan, 433004
    • Research Site
  • Tainan, Taiwan, 70403
    • Research Site
  • Tainan, Taiwan, 710
    • Research Site
  • Taipei, Taiwan, 100
    • Research Site
  • Taipei, Taiwan, 110
    • Research Site
  • Taipei, Taiwan, 116
    • Research Site
  • Taoyuan, Taiwan, 333
    • Research Site
  • Zhubei, Taiwan, 302
    • Research Site
• Vietnam
  • Da Nang, Vietnam, 55000
    • Research Site
  • Hanoi, Vietnam, 100000
    • Research Site
  • Hanoi, Vietnam, 10000
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Research Site
  • Hochiminh City, Vietnam, 700000
    • Research Site
  • Hà Nội, Vietnam, 100000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balcinrenone/dapagliflozin; Patient receives once daily 1 capsule balcinrenone 15 mg and dapagliflozin 10 mg and 1 placebo tablet matching dapagliflozin.	Drug: Balcinrenone/dapagliflozin; balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
Active Comparator: Dapagliflozin; Patient receives once daily 1 placebo capsule matching balcinrenone and dapagliflozin and 1 tablet dapagliflozin 10 mg.	Drug: Dapagliflozin; dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 to first occurrence of any of the components of the composite: CV death; Death from kidney failure; Onset of kidney failureInitiation of maintenance dialysis orKidney transplantation; Sustained ≥ 50% decline from baseline in eGFR; HF with or without hospitalisation	Up to 46 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from randomization to first occurrence of cardiovascular death, death from kidney failure, kidney failure and sustained 50% or greater decline in eGFR.	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 orKidney transplantation Sustained ≥ 50% decline from baseline in eGFR	Up to 46 months.
Change from baseline in urinary albumin to creatinine ratio to Week 24	Change from baseline to Week 24 in urinary albumin to creatinine ratio, assessed from spot urine albumin and creatinine measurements	Baseline to Week 24
Time from randomization to first occurrence of cardiovascular death or heart failure event.	Time to first occurrence of any of the components of the composite: CV death; HF with or without hospitalisation	Up to 46 months.
Time from randomization to cardiovascular death	Time from randomization to cardiovascular death.	Up to 46 months.
Time from randomization to death from any cause	Time from randomization to death from any cause.	Up to 46 months.

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; dapagliflozin
• Other Study ID Numbers: D8790C00001; 2026-526114-90-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Researchers may see summary results, but they will not be able to see individual participant data or any personal identifiers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No