Who is eligible for clinical trial NCT07624305?

Participants must meet the protocol's inclusion criteria for Renal Insufficiency, Chronic. The stated age range is 18 Years to 99 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07624305 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-29

A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD) (NCT07624305)

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)

🟡 Not Yet Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: AstraZeneca

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (23 items).

Location: Research Site — Ciudad de Buenos Aires

Age range: 18 Years to 99 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (45 Sites)

Showing the first 25 of 45 sites.

Research Site — Ciudad de Buenos Aires,
Research Site — Edmonton, Alberta
Research Site — Winnipeg, Manitoba
Research Site — London, Ontario
Research Site — Toronto, Ontario
Research Site — Waterloo, Ontario
Research Site — Halifax,
Research Site — Magdeburg,
Research Site — Kita-ku,
Research Site — Osaka,
Research Site — Olsztyn,
Research Site — Warsaw,
Research Site — Warsaw,
Research Site — Węgrów,
Research Site — Wroclaw,
Research Site — Żywiec,
Research Site — Anyang,
Research Site — Cheonan-si,
Research Site — Seoul,
Research Site — Seoul,
Research Site — Seoul,
Research Site — Seoul,
Research Site — Seoul,
Research Site — Changhua,
Research Site — Hualien City,

📞 Contact the Study Coordinator

Phone: (877) 240-9479

Email: information.center@astrazeneca.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Renal Insufficiency, Chronic

SDCC - Prospective Cohort Study of Chronic Renal Insufficiency — Oakland, California
Neurovascular Transduction During Exercise in Chronic Kidney Disease — Atlanta, Georgia

Explore by condition: All Renal Insufficiency, Chronic clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗