Jerantut

Researchers are evaluating the effects of felzartamab in adults with Immunoglobulin A nephropathy (IgAN), a kidney disease caused by the buildup of abnormal IgA antibodies in the kidneys. This buildup leads to inflammation and damage, causing protein to appear in the urine. The study aims to understand how felzartamab influences proteinuria and kidney function, while also assessing the safety and how the body processes this treatment. This is a Phase 3, randomized, double-blind, placebo-controlled study focusing on adults with IgAN. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous (IV) infusions. Neither the participants nor the researchers will know which treatment is given. The treatment period lasts 24 weeks followed by an 80-week follow-up period. In total, participants will attend 17 study visits over about 2 years to receive infusions and participate in study activities. During the study, participants will undergo assessments including urine tests to measure protein levels, kidney function evaluations, and safety monitoring. Researchers will track changes in proteinuria from the start of the study to Week 36 as the main outcome. Additional measurements will include kidney function, clinical endpoints, and the study of how felzartamab is processed by the body. Participant safety and long-term effects will be monitored throughout the study and follow-up periods.

Researchers are studying the effects and safety of felzartamab, a laboratory-made monoclonal antibody, in adults with primary membranous nephropathy (PMN), a condition where harmful autoantibodies build up in the kidney filters causing damage. This damage leads to protein leaking into the urine, swelling, tiredness, and high blood pressure, which can progress to kidney failure if untreated. The study aims to compare felzartamab to tacrolimus, a standard oral medication, to see how well each helps achieve complete remission of proteinuria and maintains kidney function over 104 weeks. Participants will be randomly assigned to receive either felzartamab through intravenous infusions or tacrolimus tablets by mouth. The study includes a screening period of up to 42 days before treatment begins. If a participant's kidney function worsens, proteinuria increases, or the disease relapses without improvement, rescue treatment options are available. Those stopping treatment early will have follow-up visits every 12 weeks until week 104. Participants without rescue treatment will continue in the study for up to 104 weeks, while those needing rescue treatment may stay for up to 156 weeks, with a total of up to 23 study visits. Throughout the study, researchers will monitor how many participants achieve complete remission, how long remission lasts, and the development of antibodies against felzartamab. They will also assess the drug's safety, how it is processed in the body, and its effects on participants' tiredness and overall physical health. Regular evaluations, including laboratory tests and patient-reported outcomes, will help understand the treatment impact and safety over the long term.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.