Kidney Week

Abstract: SA-OR087

Efficacy and Safety of Balcinrenone in Combination with Dapagliflozin on Albuminuria in Participants with CKD

Session Information

• High-Impact Clinical Trials - 2
  November 08, 2025 | Location: Hall A, Convention Center
  Abstract Time: 11:45 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

• Heerspink, Hiddo Jan L., University Medical Center Groningen, Groningen, Netherlands

Hiddo Jan L. Heerspink, PhD

• Cardona, Jose F, Indago Research & Health Center, Hialeah, Florida, United States

Jose F Cardona, MD

• Jolly, Shivinder Singh, Clinical Research Solutions Inc, Waterloo, Ontario, Canada

Shivinder Singh Jolly, MD

• Pergola, Pablo E., Renal Associates PA, San Antonio, Texas, United States

Pablo E. Pergola, MD, PhD

• De Sousa Amorim, Erika, AstraZeneca, Warsaw, Poland

Erika De Sousa Amorim

• Eriksson, Anna, AstraZeneca, Gothenburg, Sweden

Anna Eriksson, MD, PhD

• Fredholm, Martin, AstraZeneca, Gothenburg, Sweden

Martin Fredholm, PhD, MD

• Gasparyan, Samvel B., AStraZeneca, Boston, Massachusetts, United States

Samvel B. Gasparyan, PhD

• Guzman, Nicolas Jose, AstraZeneca, Gaithersburg, Maryland, United States

Nicolas Jose Guzman, MD

• Hartleib-Geschwindner, Judith, AstraZeneca, Gothenburg, Sweden

Judith Hartleib-Geschwindner, PhD

• Jiang, Yunyun, AstraZeneca, Gaithersburg, Maryland, United States

Yunyun Jiang, MS, PhD

• Leonsson Zachrisson, Maria, AstraZeneca, Gothenburg, Sweden

Maria Leonsson Zachrisson, MD, PhD

• Mark, Patrick Barry, University of Glasgow, Glasgow, United Kingdom

Patrick Barry Mark, MBChB, PhD

Background

SGLT2is reduce albuminuria and the risk of CKD progression, and the MRA finerenone has similar effects in T2D with CKD. We assessed the albuminuria-lowering efficacy and safety of the novel MRA balcinrenone combined with the SGLT2i dapagliflozin.

Methods

In this double-blind, active-controlled clinical trial (NCT06350123), adults with eGFR of 25–<60 mL/min/1.73 m², UACR of >100–5000 mg/g, and potassium 3.5–5.0 mmol/L, were randomized 1:1:1 to combined balcinrenone/dapagliflozin 15/10 mg, balcinrenone/dapagliflozin 40/10 mg, or placebo/dapagliflozin 10 mg as adjunct to RAS inhibitors for 12 weeks, followed by an 8-week wash-out period. Primary endpoint was change in UACR from baseline to week 12.

Results

Of 613 participants screened, 324 were randomized (mean age 65 years [SD 12]; mean eGFR 42 mL/min/1.73 m² [SD 11], median UACR 365 mg/g [25^th, 75^th percentile 157, 825], and 56% taking SGLT2i). Balcinrenone/dapagliflozin 15/10 mg and balcinrenone/dapagliflozin 40/10 mg were superior in reducing UACR vs. placebo/dapagliflozin (Figure 1A). At week 12, UACR difference vs. placebo/dapagliflozin was –22.8% (90% CI –33.3 to –10.7; p=0.0038) for balcinrenone/dapagliflozin 15/10 mg and –32.8% (90% CI –42.0 to –22.1; p<0.001) for balcinrenone/dapagliflozin 40/10 mg. Minor changes were observed in potassium (Figure 1B). Investigator-reported adverse events of hyperkalaemia occurred in 6%, 7%, and 5% of participants in the balcinrenone/dapagliflozin 15/10 mg, balcinrenone/dapagliflozin 40/10 mg, and placebo/dapagliflozin groups, respectively.

Conclusion

In participants with CKD, combined balcinrenone and dapagliflozin was superior to dapagliflozin in reducing albuminuria. The combination was well-tolerated with minor effects on potassium.

Funding

• Commercial Support – AstraZeneca

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.2025tvnjdpaq