Kidney Week

Abstract: SA-PO0194

Crovalimab for Atypical Hemolytic Uremic Syndrome in Pediatric Patients: The Phase 3 COMMUTE-p Trial

Session Information

• Tubular, Metabolic, and Systemic Noncystic Genetic Kidney Diseases
  October 24, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Genetic Diseases of the Kidneys

• 1202 Genetic Diseases of the Kidneys: Non-Cystic (Complex and Non-Cystic Monogenic)

Authors

• Vaisbich, Maria H., Universidade de São Paulo, Instituto da Criança, Hospital das Clínicas (HCFMUSP), São Paulo, Brazil

Maria H. Vaisbich, MD, PhD

• Dixon, Bradley P., Department of Pediatrics, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

Bradley P. Dixon, MD, FASN

• Fakhouri, Fadi, Department of Nephrology and Hypertension, Lausanne University Hospital, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

Fadi Fakhouri, MD

• Lapeyraque, Anne-Laure, Nephrology Unit, Department of Pediatrics, Université de Montréal, Montréal, Quebec, Canada

Anne-Laure Lapeyraque

• Mauch, Teri Jo, University of Nebraska Medical Center Department of Pediatrics, Omaha, Nebraska, United States

Teri Jo Mauch

• Sethi, Sidharth Kumar, Pediatric Nephrology & Kidney Transplant, Artemis Hospitals, Gurgaon, Haryana, India

Sidharth Kumar Sethi, MD, FASN

• Sinha, Aditi, Division of Nephrology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India

Aditi Sinha, MD, MBBS, PhD

• Leon, Patty G., Genentech, Inc, South San Francisco, California, United States

Patty G. Leon, PhD

• Buri, Muriel, F. Hoffmann-La Roche Ltd., Basel, Switzerland

Muriel Buri

• Sreckovic, Sasha, Genentech, Inc, South San Francisco, California, United States

Sasha Sreckovic, MD

• Greenbaum, Larry A., Division of Nephrology, Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, United States

Larry A. Greenbaum, MD, PhD

Background

COMMUTE-p (NCT04958265) is a single-arm Phase III study of crova, a novel C5 inhibitor (C5i) that allows for low-volume subcutaneous administration up to every 4 wks, in pediatric pts with aHUS. Primary analysis (PA) results are shown.

Methods

Pts aged ≥28 days to <18 years and weighing ≥5 kg enrolled into C5i-naive or switch (if switching from ecu/ravu) cohorts received weight-based tiered crova during a 24-wk primary treatment period, followed by an optional continuation period. Efficacy was assessed during the first 24 wks. The primary efficacy endpoint (EP) was the proportion of naive pts with cTMAr from BL to Wk25. Key secondary efficacy EPs included time to cTMAr, mTMAc from BL–Wk25, change from BL in dialysis status, CKD stage, eGFR, and platelet normalization. Exploratory EPs included time to dialysis discontinuation (post-hoc), hemoglobin response, and treatment preference (assessed in adolescent switch pts and caregivers at Wk17). Fatigue was assessed with PedsQL-MFS. Safety was assessed until the PA clinical cutoff date (July 4, 2025).

Results

21 naive and 20 switch pts enrolled. cTMAr was achieved in 70.6% of naive pts (median onset 61.0 days), with consistent results seen for secondary/exploratory EPs (Table). 100% of switch pts had mTMAc; strong treatment preference for crova was seen. 92.3% of naive pts had improved CKD stage. 100% of naive pts who were on dialysis at BL became dialysis-independent by Wk25. Median time to dialysis discontinuation was 1.6 wks. Most switch pts (75.0%) had stable/improved CKD. Crova was well tolerated (Table). There were no transient immune complex reactions in switch pts.

Conclusion

These data support crova's efficacy and favorable benefit–risk profile in pediatric aHUS.
Previously submitted: ERA 2026.

Funding

• Commercial Support – F. Hoffmann-La Roche Ltd