Kidney Week

Abstract: FR-OR109

Isuzinaxib Preserves Kidney Function in Patients with CKD Undergoing Percutaneous Coronary Intervention for Contrast-Induced AKI: A Randomized, Double-Blind, Phase 2 Trial

Session Information

• Late-Breaking Research Orals: AKI, CKD, CKM, and More
  October 23, 2026 | Location: Four Seasons Ballroom 2, Convention Center
  Abstract Time: 04:42 PM - 04:54 PM

Category: Acute Kidney Injury

• 102 AKI: Clinical, Outcomes, and Trials

Authors

• Gwon, Hyeon-Cheol, Samsung Medical Center, Gangnam-gu, Seoul, Korea (the Republic of)

Hyeon-Cheol Gwon, MD, PhD

• Cha, Dae R., Korea University Ansan Hospital, Ansan-si, Gyeonggi-do, 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, PhD

• 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) and subsequent kidney function decline. Isuzinaxib, an oral pan-NOX inhibitor, targets oxidative stress-mediated kidney injury.

Methods

In this randomized, double-blind, placebo-controlled phase 2 trial (NCT05758896), patients with CKD (eGFR 30–90 mL/min/1.73 m²) undergoing PCI were randomized 1:1 to Isuzinaxib 400 mg once daily or placebo from ≤ 48 hours before through 2 days after PCI.
The primary endpoint was safety. Secondary endpoints assessed kidney function from the acute CI-AKI phase through the acute kidney disease (AKD) period associated with CKD progression, and included changes in serum creatinine and eGFR through Week 12.

Results

A total of 159 participants (Isuzinaxib, n=81; Placebo, n=78) with mean screening eGFR 62.8±15.7 vs. 63.5±16.3 mL/min/1.73 m² underwent PCI.
Safety was comparable between groups, with no unexpected safety findings.
CI-AKI occurred in 6.2% with Isuzinaxib vs. 5.1% with placebo. At Week 12, adjusted LS mean relative eGFR changes were −1.8% with Isuzinaxib and −7.4% with placebo (ANCOVA difference, 5.6%; 95% CI, 1.0–10.3; p=0.02). Longitudinal MMRM sensitivity analyses supported the eGFR and serum creatinine changes through 12 weeks (Figure 1).
In an exploratory screening eGFR <60 subgroup (CKD G3, n=68), LS mean relative eGFR changes at Week 12 were −0.9% with Isuzinaxib vs. −9.9% with placebo (ANCOVA difference, 9.0%; 95% CI, 2.1 to 15.9; p=0.01). Treatment differences were consistent across analyses at Week 12 within the AKD period and numerically more pronounced in the subgroup with more advanced CKD.

Conclusion

Peri-procedural treatment with Isuzinaxib was safe and well tolerated and showed potential to preserve kidney function through Week 12 compared with placebo. These results support the development of Isuzinaxib as a kidney-protective strategy following contrast exposure during PCI in patients with CKD.

Figure 1. MMRM-adjusted LS mean (SE) relative change in eGFR (%) (A) and absolute change in serum creatinine (mg/dL) (B) over time by treatment group.

Funding

• Commercial Support – Aptabio Therapeutics Inc.