Actively Recruiting
Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
Led by Otsuka Pharmaceutical Development & Commercialization, Inc. · Updated on 2025-04-06
25
Participants Needed
5
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 16 years of age or older at the time of signing the informed consent or assent
- Diagnosis of IgA nephropathy confirmed by a source-verified kidney biopsy
- Estimated glomerular filtration rate (eGFR) greater than 45 mL/min/1.73 m2 based on serum creatinine using appropriate equations for age
You will not qualify if you...
- Breastfeeding or positive pregnancy test before receiving sibeprenlimab
- Presence of chronic kidney disease other than IgA nephropathy
- Serum IgG value less than 600 mg/dL at screening
- Current or recent (within 24 weeks) use of systemic corticosteroids or immunosuppressive therapy (topical, ophthalmic, rectal, intra-articular, and inhaled corticosteroids allowed)
- Uncontrolled hypertension with systolic blood pressure over 140 mmHg or diastolic blood pressure over 90 mmHg
- Likely need for prohibited concomitant therapy during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Clinical Research Site 330
Denver, Colorado, United States, 80230
Actively Recruiting
2
Clinical Research Site 369
Boston, Massachusetts, United States, 21144
Actively Recruiting
3
Clinical Research Site 374
Dakota Dunes, South Dakota, United States, 57409
Actively Recruiting
4
Clinical Research Site 324
Houston, Texas, United States, 77054
Actively Recruiting
5
Clinical Research Site 305
Scarborough Village, Ontario, Canada, M1H 3G4
Actively Recruiting
Research Team
O
Otsuka Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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