Abstract: FR-PO0817
Evaluation of Hematuria in Patients Treated with Ravulizumab in the Phase 2 SANCTUARY Trial
Session Information
- Glomerular Clinical Trials: From Data to Impact
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Kaufeld, Jessica Katharina, Department of Nephrology and Hypertension, Hannover Medical School, Hannover, Germany
- Lafayette, Richard A., Stanford Glomerular Disease Center, Stanford University Medical Center, Stanford, California, United States
- Uriol Rivera, Miguel, Son Espases University Hospital, Glomerular Diseases Unit, Palma, Spain
- Han, Seung Hyeok, Renal Electrolyte and Hypertension Division, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, United States
- Lai, Ping chin, The Kidney Institute and Division of Nephrology, China Medical University Hospital, Taichung, Taiwan
- Maillard, Nicolas, Department of Nephrology, Dialysis, Transplantation, CHU de Saint-Etienne, GIMAP, EA3064, Université Jean Monnet, COMUE Université de Lyon, Rhône-Alpes, France
- Schreiber, Adrian, Department of Nephrology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany
- Fenoglio, Roberta, San Giovanni Bosco Hub Hospital, ASL Citta` di Torino, Department of Clinical and Biological Sciences of the University of Turin, Turin, Italy
- Garlo, Katherine, Clinical development, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, United States
- Rice, Kara, Biostatistics, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, United States
- Kateifides, Andreas, Clinical development, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, United States
- Farag, Youssef MK, Clinical development, Alexion, AstraZeneca Rare Disease, Boston, Massachusetts, United States
- Barratt, Jonathan, Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom
- Nowicki, Michal P., Department of Nephrology, Hypertension and Kidney Transplantation, Medical University of Lodz, Lodz, Poland
Background
In a phase 2 trial (NCT04564339) in adults with IgA nephropathy (IgAN), ravulizumab (RAV), a complement C5 inhibitor, led to reduction in proteinuria. Hematuria may reflect morphological changes at the glomerular filtration barrier, could be toxic to the tubules, and may be valuable in assessing prognosis and response to treatment. Evaluating hematuria could enhance understanding of the benefits of complement blockade in IgAN.
Methods
In this phase 2 trial, patients (pts) were randomized (2:1) to RAV (IV; q8w) or placebo (PBO) for 26 weeks (wks) followed by a 24-wk open-label RAV treatment period. Single void collections for random spot urine samples were used for hematuria evaluation, assessed by examination of the spun urine sediment by microscopy (expressed as red blood cells [RBCs]/high-power field [HPF]). The number of RBCs in urine was summarized by treatment group using frequency statistics for categorical variables. Prespecified analysis included the percentage of pts with <10 RBCs/HPF on urine sediment from spot samples, as reported by the central lab from baseline (BL) to wk 50.
Results
In the RAV group, 76.7%, 87.8%, and 90.2%, at BL, wk 26, and wk 50, respectively, had <10 RBCs/HPF (Figure). In the PBO group, 69.6% and 77.3% had <10 RBCs/HPF at BL and wk 26, respectively; at wk 50, following crossover to RAV, 100% had <10 RBCs/HPF.
Conclusion
A trend in reduction in hematuria with RAV treatment might reflect the anti-inflammatory effect and improved disease control under complement inhibition.
Funding
- Commercial Support – Alexion, AstraZeneca Rare Disease, Boston, MA, United States