Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
Purpose
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.
Condition
- IgA Nephropathy
Eligibility
- Eligible Ages
- Over 16 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Sibeprenlimab |
|
Recruiting Locations
Clinical Research Site 330
Denver, Colorado 80230
Denver, Colorado 80230
Contact:
Otsuka Call Center
Otsuka Call Center
Clinical Research Site 369
Boston, Massachusetts 21144
Boston, Massachusetts 21144
Contact:
Otsuka Call Center
Otsuka Call Center
Clinical Research Site 374
Dakota Dunes, South Dakota 57409
Dakota Dunes, South Dakota 57409
Contact:
Otsuka Call Center
Otsuka Call Center
Clinical Research Site 324
Houston, Texas 77054
Houston, Texas 77054
Contact:
Otsuka Call Center
Otsuka Call Center
More Details
- Status
- Recruiting
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.