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

NCT07624305 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: D8790C000012026-526114-90-00
• Study Type: interventional
• Target: 2,800
• Locations: 8 countries
• Sites: 45

Brief 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.

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (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

  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

  Up to 46 months.

Secondary Outcomes (5)

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

  Up to 46 months.

• Change from baseline in urinary albumin to creatinine ratio to Week 24

  Baseline to Week 24

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

  Up to 46 months.

• Time from randomization to cardiovascular death

  Up to 46 months.

• Time from randomization to death from any cause

  Up to 46 months.

Study Arms (2)

Balcinrenone/dapagliflozin

EXPERIMENTAL

Patient receives once daily 1 capsule balcinrenone 15 mg and dapagliflozin 10 mg and 1 placebo tablet matching dapagliflozin.

Drug: Balcinrenone/dapagliflozin

Dapagliflozin

ACTIVE COMPARATOR

Patient receives once daily 1 placebo capsule matching balcinrenone and dapagliflozin and 1 tablet dapagliflozin 10 mg.

Drug: Dapagliflozin

Interventions

Balcinrenone/dapagliflozin DRUG

balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg

Balcinrenone/dapagliflozin

Dapagliflozin DRUG

dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

Dapagliflozin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (45)

Research Site

Ciudad de Buenos Aires, C1425AGC, Argentina

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Edmonton, Alberta, T6G 2P4, Canada

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Winnipeg, Manitoba, R2V 3M3, Canada

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London, Ontario, N6A 5A5, Canada

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Toronto, Ontario, M4G 3E8, Canada

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Waterloo, Ontario, N2T 0C1, Canada

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Halifax, NS B3H 2Y9, Canada

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Magdeburg, 39120, Germany

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Kita-ku, 144-0001, Japan

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Osaka, 553-0003, Japan

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Olsztyn, 10-561, Poland

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Warsaw, 02-507, Poland

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Warsaw, 04-141, Poland

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Węgrów, 07-100, Poland

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Wroclaw, 50-981, Poland

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Żywiec, 34-300, Poland

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Anyang, 14068, South Korea

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Cheonan-si, 31151, South Korea

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Seoul, 03181, South Korea

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Seoul, 03312, South Korea

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Seoul, 04401, South Korea

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Seoul, 06351, South Korea

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Seoul, 08308, South Korea

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Changhua, 500, Taiwan

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Hualien City, 970473, Taiwan

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Kaohsiung City, 813, Taiwan

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Kaohsiung City, 833, Taiwan

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New Taipei City, 220216, Taiwan

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Taichung, 40201, Taiwan

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Taichung, 404, Taiwan

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Taichung, 40705, Taiwan

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Taichung, 433004, Taiwan

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Tainan, 70403, Taiwan

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Tainan, 710, Taiwan

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Taipei, 100, Taiwan

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Taipei, 110, Taiwan

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Taipei, 116, Taiwan

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Taoyuan, 333, Taiwan

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Zhubei, 302, Taiwan

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Da Nang, 55000, Vietnam

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Hanoi, 100000, Vietnam

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Hanoi, 10000, Vietnam

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Hà Nội, 100000, Vietnam

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Ho Chi Minh City, 700000, Vietnam

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Hochiminh City, 700000, Vietnam

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MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

+18772409479; information.center@astrazeneca.com

AstraZeneca Clinical AstraZeneca Clinical

CONTACT

+18772409479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel groups

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (6); DE (1); AR (1); PL (6); JP (2); TW (16); KR (7); CA (6)