Zigakibart for IgA Nephropathy

(SHIFT Trial)

This trial explores the effects of a treatment called zigakibart on IgA nephropathy (IgAN), a kidney disease that can impair kidney function over time. Participants will receive zigakibart injections every other week for two years to determine if it can slow the disease's progression. Suitable candidates for this trial have been diagnosed with primary IgAN within the last five years, continue to have protein in their urine despite treatment, and do not have other kidney-related conditions. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

The trial requires that you have not used certain medications like complement pathway inhibitors, mycophenolic acids, or corticosteroids within 12 months before screening. If you're currently on these or similar treatments, you may need to stop them to participate.

Research has shown that zigakibart is safe in previous studies. In past trials, patients with IgA nephropathy who received zigakibart every two weeks generally tolerated the treatment well. Most participants did not experience serious side effects. Long-term data indicate that zigakibart remains safe even after 100 weeks of use. These findings suggest that zigakibart could be a safe option for treating IgA nephropathy.¹²³⁴⁵

Zigakibart is unique because it offers a new approach to treating IgA Nephropathy. Unlike traditional treatments that mainly focus on managing symptoms with drugs like corticosteroids or blood pressure medications, zigakibart is an experimental therapy administered through injections every two weeks. This treatment targets the underlying disease processes more directly, potentially offering a more effective and targeted intervention. Researchers are excited about zigakibart because it may improve kidney function more effectively and with fewer side effects compared to current options.

Research has shown that zigakibart, the investigational treatment in this trial, may help treat IgA nephropathy (IgAN). Studies found that after 100 weeks, protein in the urine decreased by 60%, a positive sign for kidney health. More than half of the patients reduced their protein levels to less than 500 mg per day, and about one-third achieved levels below 300 mg. These results indicate that zigakibart helped maintain kidney function over time. The evidence suggests that zigakibart is both safe and effective for managing IgAN.¹⁶⁷⁸⁹