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Kidney Week

Abstract: SA-PO1179

BP and Urine Albumin-to-Creatinine Ratio Lowering by Baxdrostat in Participants in the FigHTN Trial

Session Information

Category: CKD (Non-Dialysis)

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

Authors

  • Dwyer, Jamie P., Division of Nephrology & Hypertension, University of Utah, Salt Lake City, Utah, United States
  • Maklad, Noha S., Late Cardiovascular, Renal, Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, United States
  • Vedin, Ola, Late-Stage Development, Cardiovascular, Renal, and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden
  • Monyak, John, Biometrics, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, United States
  • Myte, Robin, Biometrics, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, United States
  • Chertow, Glenn M., Departments of Medicine, Epidemiology and Population Health, and Health Policy, Division of Nephrology, Stanford University School of Medicine, Stanford, California, United States
  • Heerspink, Hiddo Jan L., Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands
  • Little, Dustin J., Late Cardiovascular, Renal, Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, United States
Background

The aldosterone synthase inhibitor baxdrostat reduced systolic blood pressure (SBP) and albuminuria in the phase 2 FigHTN trial (NCT05432167) of participants with CKD and hypertension. We performed pre-specified subgroup analyses to evaluate the consistency of these effects.

Methods

Adults with eGFR 25–75 mL/min/1.73m2, urine albumin-creatinine ratio (UACR) ≥100 mg/g, and SBP ≥140 mmHg (without type 2 diabetes) or ≥130 mmHg (with type 2 diabetes) were randomly assigned (1:1:1) to baxdrostat low-dose (0.5 mg up-titrated to 1 mg), high-dose (2 mg up-titrated to 4 mg) or placebo for 26 weeks. The primary endpoint was change from baseline in mean seated SBP at Week 26 in the baxdrostat pooled treatment group versus placebo. Percent change from baseline in UACR was a pre-specified exploratory endpoint. We pre-specified subgroups according to baseline disease characteristics and concomitant medications, and calculated interaction p-values.

Results

Compared to placebo, baxdrostat (pooled) resulted in a least square mean change in seated SBP from baseline to Week 26 of –8.1 (95% CI –13.4, –2.8) mmHg, and a mean percent change from baseline in UACR to week 26 of –55.2 (95% CI –67.4, –38.3)%. Results within subgroups were generally consistent with the overall results (Figures 1, 2), with overlapping 95% CI and interaction p-values supporting consistent reduction in SBP and UACR across subgroups.

Conclusion

Baxdrostat consistently reduced SBP and UACR among subgroups of participants with CKD and HTN.

Funding

  • Commercial Support – AstraZeneca

Digital Object Identifier (DOI)