Kidney Week

Abstract: SA-PO1180

Exploring Approaches with Lower Targets of Blood Pressure and Lipids for Improving Kidney Outcomes in Advanced CKD: Design of the EXCELSIOR-CKD Trial

Session Information

• CKD: Biomarkers and Emerging Tools for Diagnosis and Monitoring
  November 08, 2025 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

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

Authors

• Han, Seung Hyeok, Yonsei University College of Medicine, Seoul, Korea (the Republic of)

Seung Hyeok Han, MD, PhD

• Chang, Tae ik, National Health Insurance Service Ilsan Hospital, Goyang-si, Gyeonggi-do, Korea (the Republic of)

Tae ik Chang, MD, PhD

• Kim, Yaerim, Keimyung University School of Medicine, Daegu, Korea (the Republic of)

Yaerim Kim, MD, PhD

• Park, Sun-Hee, Kyungpook National University, Daegu, Korea (the Republic of)

Sun-Hee Park, MD, PhD

• Ko, Gang-Jee, Korea University Ansan Hospital, Ansan-si, Gyeonggi-do, Korea (the Republic of)

Gang-Jee Ko, MD, PhD

• Kim, Yong Chul, Seoul National University College of Medicine, Seoul, Korea (the Republic of)

Yong Chul Kim, MD, PhD

• Kim, Jwa-kyung, Hallym University Medical Center, Pyeongchon, Gyeonggi-do, Korea (the Republic of)

Jwa-kyung Kim, MD, PhD

• Shin, Jungho, Chung-Ang University, Seoul, Korea (the Republic of)

Jungho Shin, MD, PhD

• Kim, Sung Gyun, Hallym University Medical Center, Pyeongchon, Gyeonggi-do, Korea (the Republic of)

Sung Gyun Kim, MD, PhD

• Lee, Jee Young, Konkuk University, Seoul, Korea (the Republic of)

Jee Young Lee, MD

• Jung, Chan-Young, Asan Medical Center, Seoul, Korea (the Republic of)

Chan-Young Jung, MD, PhD

• Chung, Byung ha, Catholic University, St. Mary's Hospital, Seoul, Korea (the Republic of)

Byung ha Chung, MD, PhD

• Park, Hoon suk, Catholic University, St. Mary's Hospital, Seoul, Korea (the Republic of)

Hoon suk Park, MD, PhD

• Lim, Jeong-Hoon, Kyungpook National University Chilgok Hospital, Chilgok, Daegu, Korea (the Republic of)

Jeong-Hoon Lim, MD, PhD

• Kim, Sejoong, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea (the Republic of)

Sejoong Kim, MD, PhD

• Park, Cheol Ho, Yonsei University College of Medicine, Seoul, Korea (the Republic of)

Cheol Ho Park, MD, PhD

• Kim, Hyung Woo, Yonsei University College of Medicine, Seoul, Korea (the Republic of)

Hyung Woo Kim, MD

Group or Team Name

• EXCELSIOR-CKD Investigators.

Background

Optimal targets for BP and lipid levels in patients with advanced CKD remain uncertain. While intensive BP and lipid control improve cardiovascular outcomes in the general population, their effects on kidney outcomes in advanced CKD (G3b–G4) are poorly defined. Patients with eGFR <45 ml/min/1.73 m² have been largely excluded from major trials and current guidelines offer limited evidence-based recommendations for this high-risk group. The EXCELSIOR-CKD trial (NCT06322056) investigates whether targeting systolic BP <120 mmHg and LDL-cholesterol <70 mg/dL can reduce CKD progression in this population.

Methods

EXCELSIOR-CKD is a prospective, multicenter, open-label, randomized controlled trial using a 2×2 factorial design. Eligible participants are adults aged ≥19 years with eGFR 15–45 ml/min/1.73 m², SBP ≥130 mmHg, and LDL ≥100 mg/dL. Patients are randomized to intensive or standard BP and lipid control. The primary endpoint is CKD progression, defined as a ≥40% decline in eGFR, sustained eGFR <10 ml/min/1.73 m², initiation of kidney replacement therapy, or renal death. Secondary endpoints include individual renal events, eGFR slope, and major adverse cardiovascular events (MACE). Sample size estimation was based on a 2×2 factorial design under a one-sided α of 2.5%, targeting hazard ratios of 0.71 for BP control and 0.65 for lipid control, with standard errors of 0.12. Assuming a 60% 3-year event rate in the standard care group and 20% dropout, a total of 640 participants will provide 80% power for BP and 94% power for lipid interventions. Thirteen academic centers across Korea are participating.

Results

The trial is currently enrolling participants. Baseline characteristics, adherence to treatment targets, and interim recruitment progress will be presented at the meeting. Final results for the primary and secondary outcomes will be reported as available.

Conclusion

The EXCELSIOR-CKD trial will provide critical evidence on whether intensive BP and lipid lowering strategies improve renal and cardiovascular outcomes in patients with advanced CKD. The findings are expected to inform future guideline recommendations in this high-risk population.

Funding

• Commercial Support – Yuhan Corp.

Digital Object Identifier (DOI)

• doi: 10.1681/ASN.20252x9v4kda