This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.
Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
Source-verified kidney biopsy confirmed diagnosis of IgAN.
Participant has estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration [CKD EPI] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 [CKiD U25] eGFR equation for those younger than 18 years)
Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
Participant has coexisting chronic kidney disease, other than IgAN.
Participant has a serum IgG value <600 mg/dL at screening.
Participant has uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg).
Single group
Sibeprenlimab
DrugSibeprelimab SC (Period 1) Sibeprelimab SC (Period 2)
Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52
Click on the lead sponsor to view all of their trials.
