Kidney Week

Abstract: TH-PO1237

Electrolyte, Water, and Blood Pressure Homeostasis with Balcinrenone and Dapagliflozin in Patients with CKD: The DapaBalci-Leap Trial

Session Information

• Late-Breaking Research Posters
  October 22, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Cardiovascular-Kidney-Metabolic Health

• 602 Cardiovascular-Kidney-Metabolic Health: Clinical

Authors

• Marton, Adriana, Klinikum Nurnberg, Nuremberg, Germany

Adriana Marton, MD

• Zaremba, Dominik, Klinikum Nurnberg, Nuremberg, Germany

Dominik Zaremba, MD

• Krause, Eric, Universitatsklinikum Erlangen, Erlangen, BY, Germany

Eric Krause

• Morisawa, Norihiko, Duke-NUS Medical School, Singapore, Singapore

Norihiko Morisawa, MD

• Bamberg, Krister, AstraZeneca BioPharmaceuticals R&D, Gothenburg, Sweden

Krister Bamberg, PhD

• Greasley, Peter J., AstraZeneca BioPharmaceuticals R&D, Gothenburg, Sweden

Peter J. Greasley, PhD

• Lim, Tzy Tiing, Duke-NUS Medical School, Singapore, Singapore

Tzy Tiing Lim

• Veelken, Roland, Klinikum Nurnberg, Nuremberg, Germany

Roland Veelken, MD, DrMed

• Morath, Christian, Klinikum Nurnberg, Nuremberg, Germany

Christian Morath, MD

• Rauh, Manfred, Universitatsklinikum Erlangen, Erlangen, BY, Germany

Manfred Rauh

• Kraetsch, Hans-Georg, Arztpraxis Dr. Kraetsch und Dr. Häusler, Schwanstetten, Germany

Hans-Georg Kraetsch, DrMed

• Krause, Holger, KfH-Nierenzentrum Lauf (Dialyse, Nephrologie), Lauf, Germany

Holger Krause, MD

• Titze, Jens, Duke-NUS Medical School, Singapore, Singapore

Jens Titze, MD

Background

MRAs offer cardiorenal protection at modest diuretic and blood pressure (BP) lowering efficacy. We assessed the renal water and electrolyte profile of the novel non-steroidal MRA balcinrenone to test the hypothesis that it does not interfere with the beneficial solute and water excretion profile of SGLT2i with dapagliflozin.

Methods

In this investigator-initiated, double-blind placebo-controlled phase 2 trial (NCT05884866), patients with stage 3 CKD were randomized to 10 mg dapagliflozin, 150 mg balcinrenone, the combination, or placebo for 28 days. Study visits were baseline, day 3 (early) and day 28 (late effect). Primary endpoint was change in glucosuria; secondary endpoints included urinary water and solutes excretion; BP and plasma K⁺ were exploratory/safety endpoints.

Results

Of 103 randomized patients 99 completed all visits (mean eGFR 48.4 mL/min/1.73 m2). Balcinrenone 150 mg had a persistent diuretic effect (Fig. 1A), caused by transient natriuresis (+0.50 mmol/kg/d; 95%CI 0.17-0.83; P<0.01) with persisting urine dilution (Fig. 1B); and reduced systolic BP by 14.1 mmHg (95% CI: 8.0-20.2; P<0.001; Fig. 1C). Dapagliflozin 10 mg caused persistent glucosuria, which only transiently increased urine volume (Fig. 1A), because the osmotic-diuretic effect of SGLT2i was eliminated by adaptive urine concentration (Fig. 1B). Combination therapy fully preserved dapagliflozin's glucosuric effect (early: +1.28 mmol/kg/d; 95% CI: 0.98-1.57; P<0.001; late: +1.22 mmol/kg/d; 95% CI: 0.86-1.59; P<0.001) and increased fractional K⁺ excretion by 3.1% (95% CI: 0.81-5.35; P<0.01). Dapagliflozin's urine-concentrating effect overrode the urine-diluting (Fig. 1B), diuretic effect (Fig. 1A) of balcinrenone, while balcinrenone's BP-lowering effect was preserved (Fig. 1C). All treatments were well tolerated. One hyperkalaemia event occurred in the balcinrenone group (diarrhoea and pre-renal AKI).

Conclusion

In stage 3 CKD, high dose treatment with balcinrenone causes sustainable diuresis and substantial BP lowering. Combination with dapagliflozin adds sustained glucosuria, improves renal K⁺ elimination, and abolishes balcinrenone's diuretic effect, while preserving the BP reduction.

Funding

• Commercial Support – Investigator-Initiated Trial funded by AstraZeneca via externally-sponsored research program ESR-21-21661. Sponsor and data ownership: Klinikum Nuremberg, Germany. PI: Adriana Marton as employee of Klinikum Nuremberg