Vila Franca De Xira

Researchers are evaluating the safety, tolerability, and effectiveness of two drugs, inebilizumab and blinatumomab, in adults with active and hard-to-treat autoimmune diseases. These diseases include systemic lupus erythematosus SLE with nephritis and rheumatoid arthritis RA. The trial aims to understand how these treatments work in different groups of participants with these conditions through multiple subprotocols. Participants will receive either inebilizumab through intravenous infusions or blinatumomab through subcutaneous injections. Different dosing schedules are used for each drug, including three or four doses for inebilizumab and various low, medium, or high doses for blinatumomab. The study is divided into subprotocols focusing on different patient groups and dosing parts. During the study, participants will be monitored for treatment-emergent adverse events and serious side effects over up to 52 weeks. Researchers will assess kidney response, disease remission, and disease activity scores at various time points. Blood tests, antibody measurements, and disease activity indices will be used to evaluate the participants responses and safety. The study lasts from the first day of treatment through week 52 with ongoing evaluations.

This trial investigates the effectiveness of elacestrant compared to standard endocrine therapy for adults with node-positive, estrogen receptor-positive ER, HER2-negative early breast cancer who are at high risk of recurrence. The study aims to understand if elacestrant can improve outcomes in this group over standard treatments. Participants will be randomly assigned to receive either 345 mg of elacestrant once daily for five years or continue with their previous standard endocrine therapy, which may include anastrozole, letrozole, exemestane, or tamoxifen. Both treatments are taken orally, and the study is open-label, meaning participants and researchers know which treatment is given. During the study, participants will be monitored for up to five years for outcomes such as invasive breast cancer-free survival, distant relapse-free survival, overall survival, and quality of life changes. Assessments include questionnaires on health status and physical functioning, symptom evaluation, and blood tests to measure elacestrant levels. Safety and adverse events will be tracked throughout and for 28 days after treatment ends.

Researchers are evaluating DMX-200 repagermanium, a drug that blocks a receptor involved in inflammation, in patients with focal segmental glomerulosclerosis FSGS who are also receiving an angiotensin II receptor blocker ARB. This Phase 3 study aims to assess the safety and effectiveness of DMX-200 compared to placebo over two years in adults and adolescents aged 12 to 17 years. The study is led by Dimerix Bioscience Pty Ltd and includes a double-blind period followed by an open-label extension to observe long-term effects. Participants receive either 120 mg of DMX-200 or a matching placebo capsule twice daily for 104 weeks during the double-blind treatment phase. Afterward, those who complete this phase may enter a two-year open-label extension where all participants receive DMX-200 twice daily. The study includes a screening and qualification period lasting 6 to 14 weeks, a possible titration phase, a stabilization phase, and a follow-up period after treatments. Throughout the trial, patients will undergo assessments including urine proteincreatinine ratio and kidney function tests like estimated glomerular filtration rate eGFR at multiple time points up to week 104 and during the extension. Safety and tolerability are closely monitored through regular evaluations, adverse event tracking, and follow-up visits. Total participation may last about 230 weeks, covering all study phases and follow-up periods.

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 studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are investigating the outcomes for mothers diagnosed with cancer during pregnancy, focusing on overall survival and the long-term development of children exposed to cancer or cancer treatments before birth. The study aims to understand how prenatal exposure to therapies like chemotherapy, radiation, or targeted treatments may affect childrens neurological and heart health as they grow. The study includes several parts initially, it registers and tracks maternal and neonatal health during pregnancy and delivery, including collecting blood samples and tissue biopsies. Emotional needs of parents facing a cancer diagnosis are assessed through questionnaires. The second part follows children exposed in utero to cancer treatments with regular check-ups at various ages up to adulthood, including neurological and cardiological exams, and optional MRI sessions. Participants will undergo scheduled assessments including blood sample collection, placental biopsies, and questionnaires for parents. Children will have neurological and heart evaluations at set ages from 6 months through 18 years, with further cardiologic monitoring every five years into adulthood. The research team monitors overall survival in mothers and developmental outcomes in children, ensuring comprehensive long-term follow-up extending potentially into the fourth decade of life for offspring.