About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Sibeprenlimab