Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
Research type
Research Study
Full title
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
IRAS ID
1010971
Contact name
Boris Reznichenko
Contact email
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization, Inc
Clinicaltrials.gov Identifier
Research summary
Immunoglobulin A nephropathy (IgAN) is a disease characterized by the abnormal presence of certain antibodies, called IgA deposits, in the kidney. IgA in the kidney can cause inflammation, which can lead to irreversible kidney failure.
Sibeprenlimab is a novel potential treatment for IgAN which has been designed to block a specific pro-inflammatory molecule that is believed to contribute to IgA deposition and kidney tissue injury. Sibeprenlimab has shown potential to improve clinical outcomes in IgAN. This trial is intended to evaluate the potential impact of sibeprenlimab on IgA deposition and kidney tissue injury. Sibeprenlimab, based on the way it affects the immune system, is predicted to lead to reductions in IgA deposition in kidney tissue, and potentially reduce inflammation. This may provide insights regarding how the drug works and could support the potential of sibeprenlimab to prevent long-term progression of the disease by blocking biological processes that contribute to kidney failure in IgAN. The study will also provide opportunity to understand the relationship between measurements in the blood and urine and kidney tissue over time in IgAN.
This study is open-label and single arm, meaning that all participants will receive sibeprenlimab. Individuals with biopsy confirmed IgA nephropathy and preserved kidney function will be eligible, unless they have recently steroids or other immunosuppressive drugs. Two academic NHS medical centers will participate. At baseline (pre-treatment), participants will be asked to undergo a biopsy, unless a recently collected clinical biopsy is available. The study observation period will be 1 year, during which the participant will receive sibeprenlimab; participants will have the opportunity to then remain in the study for another year of treatment, after which participants will be asked to provide a third biopsy.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0018
Date of REC Opinion
3 Mar 2025
REC opinion
Further Information Favourable Opinion