Bloomfield

Researchers are evaluating the safety, tolerability, and effect on albuminuria of the drug MZE829 in adults with proteinuric chronic kidney disease who carry the APOL1 high risk genotype. This open-label Phase 2 study focuses on participants with proteinuria and the specific genetic risk factors G1G1, G2G2, or G1G2. The study aims to better understand how MZE829 impacts kidney disease in this targeted group. Participants will receive MZE829 capsules taken orally. The study includes two groups one with chronic kidney disease and concurrent diabetes, and another with chronic kidney disease without diabetes. The treatment period lasts 12 weeks, during which safety and tolerability will be closely monitored along with the drugs effect on albuminuria. This design allows researchers to assess the drugs impact across different patient profiles. During the study, participants will be monitored from Day 1 through Week 12 with regular assessments for adverse events and measurement of albuminuria reduction. Researchers will also track plasma drug concentrations to understand how the body processes MZE829. Safety and tolerability will be evaluated based on the incidence of any adverse events throughout the 12-week treatment period. The total duration involves close observation and follow-up during this timeframe to evaluate the study outcomes.

Researchers are conducting a combined phase 2b and phase 3 study to evaluate the drug CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing dialysis. The study focuses on participants with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. The trial aims to find the best dose of CSL300 and then assess its effects on cardiovascular outcomes and safety compared to a placebo. The study is divided into two parts Part 1 phase 2b is a dose-finding phase where different doses of CSL300 are given intravenously to participants to determine the optimal dose versus placebo. Part 2 phase 3 evaluates the efficacy and safety of the selected CSL300 dose compared to placebo over approximately five years. All treatments are administered by intravenous infusion. Participants will be involved in regular assessments including blood tests to measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events tracking, and monitoring for adverse events. The phase 2b portion includes up to 24 weeks of follow-up for dose evaluation, while the phase 3 portion monitors cardiovascular outcomes like heart attacks or cardiovascular death over about five years. Safety and drug levels in the blood will also be closely observed throughout the study.

Researchers are evaluating the efficacy, safety, tolerability, and pharmacokinetics of VX-147 in adults and children aged 10 to 65 with apolipoprotein L1 APOL1-mediated proteinuric kidney disease. This condition involves kidney damage characterized by protein in the urine. The study is a combined Phase 23 adaptive, double-blind, placebo-controlled clinical trial sponsored by Vertex Pharmaceuticals Incorporated. Participants will be randomly assigned to receive different doses of VX-147 tablets or matching placebo tablets. They will take the assigned treatment for at least 96 weeks in Part A. Those who complete Part A will continue receiving VX-147 for an additional 96 weeks in Part B. The study uses a quadruple masking design to keep treatment assignments confidential. Throughout the study, participants will undergo regular assessments including urine protein to creatinine ratio UPCR and estimated glomerular filtration rate eGFR slopes to monitor kidney function. Safety is monitored by tracking adverse events and serious adverse events over several years. Blood samples will measure VX-147 levels, and treatment acceptability will be assessed in pediatric participants. Total participation may last up to approximately four years, with ongoing safety and efficacy evaluations.