Actively Recruiting
A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy
Led by Otsuka Pharmaceutical Development & Commercialization, Inc. · Updated on 2025-04-06
25
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a phase 2b open-label trial to study immunoglobulin A nephropathy (IgAN), a kidney disease. The study aims to identify tissue biomarkers of the disease and observe potential changes in response to the drug sibeprenlimab. This research is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. and focuses on adolescents and adults with IgAN confirmed by kidney biopsy. Participants will receive sibeprenlimab through subcutaneous injections during the study. The trial includes repeat kidney biopsies to evaluate histopathology changes in the kidney tissue. The main focus is to assess changes in glomerular IgA deposition by immunofluorescence from the start of the study to week 52. During the participation, individuals will undergo kidney biopsies and monitoring of kidney function, including estimated glomerular filtration rate (eGFR). Researchers will also monitor safety and any changes in kidney tissue over the yearlong study period. The total duration of participation includes screening and treatment up to 52 weeks with follow-up evaluations.
CONDITIONS
Brief 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/assent.
- Diagnosis of immunoglobulin A nephropathy confirmed by source-verified kidney biopsy.
- Estimated glomerular filtration rate (eGFR) greater than 45 mL/min/1.73 m2 using appropriate serum creatinine equations depending on age.
You will not qualify if you...
- Breastfeeding or positive pregnancy test prior to receiving sibeprenlimab.
- Coexisting chronic kidney disease other than immunoglobulin A nephropathy.
- Serum IgG value less than 600 mg/dL at screening.
- Current or recent (within 24 weeks) use of systemic corticosteroids or immunosuppression, except allowed topical or inhaled corticosteroids.
- Uncontrolled hypertension defined as 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 52 weeks
Participants receive sibeprenlimab as an investigational drug to evaluate its impact on kidney histopathology in immunoglobulin A nephropathy.
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
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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