Mishawaka

Researchers are evaluating the effects of a medicine called BI 764198 in adults and adolescents who have a kidney condition known as focal segmental glomerulosclerosis FSGS. This Phase 3 clinical trial aims to determine whether BI 764198 helps improve kidney function in people with primary FSGS or genetic FSGS linked to TRPC6 gene variants. The study is randomized and placebo-controlled, meaning participants are randomly assigned to receive either the medicine or a placebo, and neither the participants nor the researchers know which treatment each person receives. Participants take either BI 764198 tablets or placebo tablets once a day for up to two years, while continuing their usual medication for FSGS. The study involves two groups running in parallel. The main treatment period lasts 104 weeks about two years, during which the participants regularly visit the study site approximately every three months. Both groups are compared to see if BI 764198 affects kidney protein levels and function. During the study, participants provide urine samples regularly to assess their kidney health. Researchers measure changes in urine protein-creatinine ratio and kidney filtration rate from the start to the end of the treatment period. Questionnaires about health-related quality of life are also completed. Doctors monitor participants health and note any side effects throughout the two years. This thorough follow-up helps understand how BI 764198 impacts kidney disease and overall well-being.

Researchers are studying influenza in children younger than 12 years to understand how the virus changes when treated with the drug baloxavir marboxil. This study has two parts Part A monitors the presence and development of specific changes in the virus before and after treatment in pediatric patients. Part B focuses on how influenza spreads within households from treated children under 12 to their family members, though no new participants will join Part B as per the latest study update. Participants receive a single oral dose of baloxavir marboxil on the first day, with the dose based on their body weight and age. Household contacts of the treated children are enrolled for observation but do not receive the drug. The study tracks viral changes and resistance at multiple points, including baseline and several days after treatment, and monitors influenza transmission within households. Throughout the study, children will undergo various tests such as local influenza and SARS-CoV-2 testing to confirm infection status. Researchers will measure how often virus mutations associated with resistance occur, changes in viral levels, and any side effects up to 29 days. For household contacts, influenza transmission and symptom development are checked on days 6 and 10. Participation involves scheduled visits and testing to gather this information, with the study expected to continue until mid-2027.

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.

Dry Eye Disease DED affects around 15 to 30 million people in the United States and creates significant social and economic challenges. A major cause of DED is blepharitis, a chronic inflammation of the eyelid margins that can lead to obstruction and loss of glands vital for tear production. Traditional care involves self-administered products like eyelid foams, gels, and pads, but these have limitations and some patients require costly in-office procedures. This research aims to evaluate whether a new disposable ocular brush, used with a common eyelid cleanser, is more effective at removing eyelid debris than the cleanser alone. Participants will be divided into two groups one using the standard treatment of Ocusoft Lid Scrub Original Foaming Eyelid Cleanser once daily, and the other using the same cleanser combined with the experimental Summit Ocular Brush for gentle scrubbing of the eyelids. The brush is disposable and replaced every two weeks. The study includes a treatment period of one month with follow-up visits at two and four weeks. Digital images and videos of the eyelids will be taken to assess debris removal. During the study, participants will complete the SPEED questionnaire and undergo slit lamp exams at each visit to evaluate blepharitis severity. The research team will analyze counts of eyelid debris, including scurfs, collarettes, and demodex mites, using blinded assessment methods. Total participation lasts about one month with two follow-up visits, each lasting no more than 15 minutes, to monitor treatment effects and collect data for comparison between the two groups.

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.

Researchers are evaluating the effects of several targeted drugsvismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclibon patients with progressive meningiomas. These tumors are growing, spreading, or worsening, and the study focuses on different genetic mutations in the tumors to match patients with the appropriate drug. The trial is a phase II study aiming to measure progression-free survival and response rates over six months, along with overall survival and adverse events. Participants are assigned to one of four groups based on their tumor mutation status. Those with SMOPTCH1 mutations receive vismodegib daily those with NF2 mutations receive FAK inhibitor GSK2256098 twice daily patients with AKT1, PIK3CA, or PTEN mutations take capivasertib twice daily on days 1-4 weekly and those with CDK pathway alterations receive abemaciclib twice daily. Treatment cycles repeat every 28 days as long as the disease does not progress or unacceptable side effects occur. After treatment, participants are followed every six months for up to five years. During the study, patients undergo regular monitoring including imaging to assess tumor size and progression, lab tests to monitor blood counts and organ function, and evaluations of side effects. Researchers track progression-free survival at six months and tumor response rates, as well as overall survival. Safety is closely observed up to four weeks after treatment ends. The total study duration includes active treatment cycles and long-term follow-up extending up to five years from registration.