Actively Recruiting
Phase 2b Study of Sibeprenlimab Treatment Effects on Kidney Tissue 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
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
Research Team
O
Otsuka Call Center
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