Kidney Week

Abstract: FR-PO0426

Clinical Outcomes of Isuzinaxib Across the AKI-to-AKD Continuum: Redefining Clinically Meaningful Kidney End Points

Session Information

• AKI: Biomarkers, Diagnostics, and Risk Prediction
  October 23, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Acute Kidney Injury

• 102 AKI: Clinical, Outcomes, and Trials

Authors

• Gwon, Hyeon-Cheol, Sungkyunkwan University School of Medicine, Suwon-si, Korea (the Republic of)

Hyeon-Cheol Gwon, MD, PhD

• Cha, Dae R., Korea University College of Medicine, Seoul, Korea (the Republic of)

Dae R. Cha, MD

• Moon, Sung Hwan, AptaBio Therapeutics Inc, Yongin-si, Gyeonggi-do, Korea (the Republic of)

Sung Hwan Moon, PhD

• Lee, Soo jin, AptaBio Therapeutics Inc, Yongin-si, Gyeonggi-do, Korea (the Republic of)

Soo jin Lee, MD

• Shin, Hyesung, AptaBio Therapeutics Inc, Yongin-si, Gyeonggi-do, Korea (the Republic of)

Hyesung Shin

Background

Patients with chronic kidney disease (CKD) undergoing percutaneous coronary intervention (PCI) are at high risk for contrast-induced acute kidney injury (CI-AKI). Isuzinaxib, a pan-NOX inhibitor targeting oxidative stress-mediated renal injury, is being evaluated for kidney preservation in this population.
Conventional AKI endpoints rely on serum creatinine changes within 48–72 hours, which are often transient and may not predict long-term renal outcomes. Acute kidney disease (AKD), defined as persistent kidney dysfunction between 7 and 90 days, may better reflect sustained renal injury and CKD progression. This analysis explores whether an AKI-to-AKD continuum framework offers a more clinically meaningful endpoint assessment.

Methods

In a phase 2, randomized, double-blind, placebo-controlled study (NCT05758896), CKD patients (eGFR 30–90 mL/min/1.73 m²) undergoing PCI were randomized 1:1 to receive Isuzinaxib orally 400 mg once daily or placebo from 48 hours prior to contrast exposure through 2 days post-PCI.
Kidney function was assessed immediately post-procedure, at 24 and 48 hours, and Weeks 4 and 12. In addition to conventional AKI assessment, an AKI-to-AKD framework incorporating longitudinal eGFR trajectories and AKD-related outcomes over 7–90 days was applied. Sentinel cohort results (n=30) are presented as exploratory observations.

Results

In preliminary analyses (n=30), early kidney injury signals during the acute AKI phase (up to 48 hours) did not clearly differentiate treatment arms. At Weeks 4 and 12, the placebo arm showed progressive creatinine increase and greater eGFR decline, whereas the Isuzinaxib arm showed relative kidney function preservation. At Week 12, mean relative eGFR reduction was -5.2% with Isuzinaxib vs. -10.4% with placebo, and AKD incidence was numerically lower with Isuzinaxib (6.7%) than placebo (20.0%).
These exploratory trends suggest that AKD-focused longitudinal assessment may better capture sustained renal outcomes than early creatinine-based AKI metrics.

Conclusion

Conventional AKI-based endpoints may not adequately reflect persistent renal dysfunction following contrast exposure. These preliminary findings suggest that AKD-focused sustained kidney function assessment may provide a more clinically relevant approach for evaluating renal outcomes and kidney preservation in high-risk PCI populations.

Funding

• Commercial Support – Aptabio Therapeutics Inc.