Shenandoah

This trial investigates MZE829 capsules in adults with proteinuric chronic kidney disease who also carry the APOL1 high risk genotype, specifically G1G1, G2G2, or G1G2 variants. The study aims to evaluate the safety, tolerability, and impact on albuminuria, a marker of kidney damage, in this population. It is an open-label Phase 2 trial, meaning all participants receive the study drug and results will help determine its effects and safety profile. Participants receive MZE829 capsules orally in a single-group design. The study includes two cohorts one with chronic kidney disease alongside diabetes, and another with chronic kidney disease without diabetes. The treatment and monitoring occur over a 12-week period, during which the study team assesses drug safety and effects on albuminuria levels. During the trial, participants will be monitored for adverse events and tolerability from baseline through week 12. Researchers will also measure changes in urine albumin-to-creatinine ratio UACR to evaluate kidney function. Blood samples will be taken to assess plasma drug concentrations. The total participation time is approximately 12 weeks, focusing on safety and biological effects of MZE829.

Researchers are evaluating the combination of Surovatamig AZD0486, a fully human bispecific monoclonal IgG4 antibody, plus rituximab versus standard immunochemotherapy regimens in adults with untreated follicular lymphoma FL. This global, randomized, open-label Phase III study aims to assess the efficacy, safety, and added benefit of this combination compared to investigator-chosen standard treatments. The study includes a safety run-in and a Phase III portion with three treatment arms. The study has two parts first, a Safety Run-in to determine the recommended Phase III dose RP3D of Surovatamig combined with rituximab second, a Phase III comparison of Surovatamig plus rituximab two dosing schedules against one of three standard chemoimmunotherapy regimens chosen by the investigator R-CVP, R-CHOP, or B-R, all followed by rituximab maintenance. Participants are assigned to one of these three arms to evaluate treatment effects. Participants will be monitored for up to 10 years, with assessments including adverse event tracking, dose adjustments, and efficacy measures such as response rates, progression-free survival, and overall survival. Evaluations involve physical exams, laboratory tests, and imaging to measure disease activity and safety. The study aims to gather long-term data on treatment impact and safety in this patient population.

This research investigates the safety and effectiveness of VIA Disc NP, a non-surgical treatment designed to supplement nucleus pulposus tissue in people experiencing lumbar discogenic pain due to degenerative disc disease DDD. The study is a randomized, sham-controlled, double-blind trial conducted across multiple centers, including an initial open-label roll-in phase for one participant per site. It focuses on adults aged 22 to 85 years with moderate to severe disc degeneration confirmed by MRI and persistent low-back pain unresponsive to conservative care. Participants receive a single intradiscal injection of VIA Disc NP, which is made from processed cadaveric disc tissue, at up to two affected lumbar levels L1-S1. Participants who enroll after the roll-in phase are randomly assigned in a 21 ratio to receive either the VIA Disc NP injection or a sham procedure where a needle is inserted but no injection is given. Those initially assigned to the sham group who continue to have symptoms after 12 months may cross over to receive VIA Disc NP and undergo an additional 12 months of follow-up. During the study, participants will be monitored through assessments including pain severity using the Visual Analog Scale VAS and safety evaluations for any treatment-related adverse events over a 12-month period. The primary outcomes measure the proportion of participants achieving meaningful improvement in pain scores and the incidence of treatment-related side effects. The study duration includes screening, treatment, and follow-up visits, with careful tracking of participants symptoms and safety throughout the trial.

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.

Researchers are evaluating the safety and effectiveness of the LINQ fusion procedure compared to conventional medical management for treating sacroiliac joint SIJ dysfunction. This is a prospective, multi-center, open-label, randomized clinical study designed to assess treatment options for adults experiencing chronic SIJ-related pain that has not responded well to non-surgical care. Participants will be randomly assigned in a 21 ratio to either receive the LINQ procedure, which involves implanting compatible bone allograft implants to prepare the SIJ for fusion, or to receive standardized, stepwise non-surgical management known as Conventional Medical Management CMM. After six months, those in the CMM group may choose to continue with this care or crossover to receive the LINQ procedure. Study visits include screening, baseline procedure or CMM initiation, and follow-up visits through 24 months. For participants who crossover, additional follow-up occurs through 18 months after the procedure. During the study, participants will have evaluations at multiple time points including 1, 3, 6, 12, 18, and 24 months. Assessments will include pain measurement using a Visual Analog Scale VAS, disability evaluation with the Oswestry Disability Index ODI, quality of life questionnaires, patient global impression of change, medication use, and monitoring of adverse events. The primary outcome is measured at six months by the composite success responder rate. Participants are expected to avoid all forms of nicotine throughout the study and comply with follow-up visits and procedures.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating the efficacy, safety, tolerability, and pharmacokinetics of VX-147 in adults and children aged 10 to 65 who have APOL1-mediated proteinuric kidney disease. This study includes participants with specific APOL1 genotypes and aims to understand how VX-147 affects kidney function over time in this population. Participants are randomly assigned to receive different doses of VX-147 or a matching placebo. Those in the initial phase Part A will receive their assigned treatment for at least 96 weeks. Participants who complete Part A will then receive VX-147 for an additional 96 weeks in Part B. The study uses tablets taken orally and includes a placebo control group. During the trial, participants will be monitored regularly for changes in urine protein to creatinine ratio and kidney function measured by estimated glomerular filtration rate eGFR. Safety and tolerability are assessed through tracking adverse events throughout the study, which may last around four years after the last participant enrolls. Blood levels of VX-147 will also be measured, and pediatric participants will be asked about their satisfaction with the tablet form.

This research aims to evaluate the Shield blood tests performance for colorectal cancer CRC screening in people aged 45 to 81 who are at average risk for CRC. The study focuses on assessing the test during a second round of screening, using colonoscopy as the reference standard. CRC is a common and serious disease, especially affecting older adults and certain minority groups, with early detection being key to improving outcomes. Participants will undergo the Shield blood test as part of their routine standard care, and their results will be compared to colonoscopy findings. This study is observational and collects real-world evidence over a period of 33 to 42 months after enrollment to assess how well the Shield test performs in detecting CRC or its precursors during the second screening interval. Participants will be involved in scheduled study procedures and standard care assessments, with data collected on the tests accuracy and effectiveness over time. The main outcome measured is the performance of the Shield test during the second testing period. The study will continue until December 2030, monitoring participants to gather long-term information about CRC screening efficacy in an average-risk population.