IgA Nephropathy
Conditions
Brief summary
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.
Interventions
DRUGSibeprenlimab
Sibeprelimab SC (Period 1) Sibeprelimab SC (Period 2)
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants must be at least 16 years of age or older at the time of signing the informed consent/assent. 2. Source-verified kidney biopsy confirmed diagnosis of IgAN. 3. 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)
Exclusion criteria
1. Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab. 2. Participant has coexisting chronic kidney disease, other than IgAN. 3. Participant has a serum IgG value \<600 mg/dL at screening. 4. Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note: topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed). 5. Participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg). 6. Participants who would be likely to require prohibited concomitant therapy during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52 | From Baseline to Week 52 |
Countries
Canada, United States
Contacts
Primary ContactOtsuka Call Center
Outcome results
None listed