Monthly Dosing of Atacicept in IgAN
Research type
Research Study
Full title
A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients with IgAN
IRAS ID
1012064
Contact name
Erin Collins
Contact email
Sponsor organisation
Vera Therapeutics Inc.
Eudract number
2025-521519-37
Research summary
This study will test an experimental medicine called atacicept in participants with immunoglobulin A nephropathy (IgAN), which is a disease that causes damage to the tiny filters (called glomeruli) inside the kidney. IgA is a type of protein (antibody) that helps the body fight infections. In people with IgAN, a modified version of the protein IgA, also known as galactose-deficient IgA1 (Gd-IgA1), builds up and forms clumps in the kidney which can damage the kidney and affect its ability to work properly. This can result in changes in urine, progressive kidney damage, and dysfunction, which may ultimately require dialysis or kidney transplant. Lowering of Gd-IgA1 can potentially reduce the damage to the glomeruli and may avoid the development of kidney failure.
Atacicept is currently being administered in research settings as a once-weekly dose. Researchers are working to make it easier for patients by seeing if it can be given as a monthly dose instead. The main goal of this study is to learn how different doses and schedules of atacicept affect the body. Researchers want to understand if monthly doses work similarly to weekly doses. In addition, the study will keep a close eye on patient safety, how well patients tolerate the drug, and how the drug affects the body in terms of effectiveness.
The study will try:
• To determine if atacicept can reduce the amount of Gd-IgA1 in the body and improve the symptoms of IgAN
• To test how safe atacicept is, identify any side effects and how bad they are
• To understand how the body processes and breaks down atacicept, including how long it stays in the body
• To understand how the immune system reacts to atacicept, including if the body tries to fight off the atacicept in the same way it fights off infections
This study will enroll approximately 90 participants who will all receive atacicept. This study will test 4 different doses of atacicept in 5 different groups. Participants will receive weekly or monthly doses.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
25/NW/0194
Date of REC Opinion
27 Aug 2025
REC opinion
Further Information Favourable Opinion