CFUB523A12302B
Research type
Research Study
Full title
A multicenter open-label extension study to evaluate the long-term safety and tolerability of zigakibart in adults with primary IgA nephropathy
IRAS ID
1013568
Contact name
Fiona Morris
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Clinicaltrials.gov Identifier
Research summary
Immunoglobulin A nephropathy (IgAN) is caused when the body’s immune system does not work the way it is supposed to. The body produces specific proteins, called immunoglobulins, which help fight infection. In IgAN, there is too much of one of these proteins, immunoglobulin A, which then builds up in the kidneys and can cause the kidneys to stop working properly.
Current standard of care therapy for IgAN is blood pressure control with certain medications to try to preserve kidney function. However, for patients with persistent proteinuria (leakage of protein into the urine) despite optimal blood pressure control, there are currently very few additional treatment options available and disease progression leads to kidney failure, resulting in dialysis or kidney transplant. Therefore, there is an unmet medical need for patients with IgAN who do not benefit from blood pressure control alone.
The proposed study is an open-label extension (OLE) study to test the long-term safety and tolerability of zigakibart in adults with primary IgAN.
In 23 countries, approximately 220 IgAN patients who have already completed another study of zigakibart will be enrolled into this OLE for at least an additional 96 weeks of treatment. All participants will receive treatment with zigakibart 600mg every 2 weeks by subcutaneous (under the skin) injections.
The study will involve the following study assessments: collection of health information and medical history, vital signs (blood pressure, heart rate, temperature), physical exam, height and weight, ECG, health questionnaires, and blood and urine samples.
REC name
Wales REC 2
REC reference
26/WA/0072
Date of REC Opinion
30 Apr 2026
REC opinion
Further Information Favourable Opinion