Jerantut

Researchers are studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

Researchers are studying primary membranous nephropathy PMN, a kidney condition where harmful autoantibodies build up in the kidney filters, causing damage. This can lead to protein and blood leaking into the urine, swelling, tiredness, and high blood pressure. The study aims to compare how the laboratory-made antibody drug felzartamab works compared to the existing drug tacrolimus in treating PMN, focusing on how many participants achieve complete remission over 104 weeks. Participants will be randomly assigned to receive either felzartamab through intravenous infusions or tacrolimus as oral tablets. Those whose disease worsens or who do not improve may receive additional rescue treatment, including standard immunosuppressive therapy or felzartamab. The study includes an open-label treatment phase and a non-responder treatment phase for those needing rescue therapy. Participants will undergo up to 23 study visits during screening and treatment, which may last up to 104 weeks or 156 weeks if rescue treatment is needed. Researchers will monitor urine protein levels, kidney function, antibody levels, physical health, and side effects. Follow-up visits every 12 weeks will continue if treatment stops early to assess long-term effects and safety.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.