Study of LUPKYNIS with Belimumab, Obinutuzumab, or Anifrolumab to Improve Kidney Health in Adults with Lupus Nephritis

What this Trial Is About

This research aims to evaluate the effectiveness and safety of LUPKYNIS combined with belimumab, obinutuzumab, or anifrolumab in adults with lupus nephritis LN. The study focuses on how well these combinations induce a rapid kidney response in patients diagnosed with LN, a condition affecting kidney health. It is a phase 4 clinical trial sponsored by Aurinia Pharmaceuticals Inc. that assesses treatment approaches for this condition. Participants will receive LUPKYNIS along with one of the biologic agents belimumab, obinutuzumab, or anifrolumab. In addition, all patients will be treated with a mycophenolic acid analog MPAA, such as mycophenolate mofetil or mycophenolic acid, and corticosteroids like prednisone or an equivalent. The biologic treatment schedules vary depending on the specific drug, with some patients already receiving treatment before the study starts or beginning it at the start of the trial. During the study, participants will be monitored for kidney response over 24 weeks, including complete and partial renal responses. Researchers will assess safety by tracking treatment-emergent adverse events up to 28 weeks. Other assessments include measuring changes in kidney-related antibodies and complement levels at baseline, 12 weeks, and 24 weeks. The total participation duration extends to about 28 weeks, during which various evaluations, laboratory tests, and safety monitoring will occur to understand treatment effects and patient outcomes.

PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis