Nambour

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.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.

Researchers are evaluating whether a new medicine called PF-08634404 combined with chemotherapy is more effective than the current standard treatment, pembrolizumab with chemotherapy, for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase 3 study focuses on adults 18 years and older with squamous or non-squamous NSCLC who are not candidates for surgery or curative chemoradiotherapy and have not received prior treatment for advanced disease. The study excludes participants with known actionable genomic alterations and aims to compare overall survival and progression-free survival over approximately 39 and 32 months, respectively. Participants are assigned to two parts based on their tumor type: squamous NSCLC patients in Part 1 and non-squamous NSCLC patients in Part 2. Within each part, participants are randomly assigned to receive either the experimental treatment PF-08634404 or the control treatment pembrolizumab, each combined with a chemotherapy regimen tailored to tumor type. Treatments are given via intravenous infusions in cycles, followed by maintenance therapy with either monotherapy or combination therapy depending on the study part. Treatment continues as long as it is beneficial and side effects remain manageable. During the study, participants will have regular visits for treatment administration and health evaluations. Cancer response will be monitored with tests every 6 weeks for the first 48 weeks and then every 12 weeks afterward. Researchers will assess overall survival and progression-free survival, ensuring thorough monitoring of participants' health and treatment effects throughout the study period.

Researchers are evaluating the impact of scaling up finger-stick point-of-care testing for hepatitis C virus (HCV) to improve diagnosis and treatment rates. This observational cohort study focuses on people at risk of HCV infection, including those attending services like drug treatment clinics, needle and syringe programs, prisons, mental health services, and homelessness support. The study aims to address declining treatment uptake and challenges caused by COVID-19, contributing to national efforts to eliminate HCV by 2030. Participants will be offered finger-stick point-of-care testing for HCV antibodies, with results available within 1 to 20 minutes. If the antibody test is positive, a point-of-care HCV RNA test will be done to detect active infection. Those previously infected or treated will directly receive the HCV RNA test. No treatment is provided within the study, but participants with active infection will be connected to standard care services for clinical assessment and treatment initiation. Participants attend a single visit for testing and to complete a self-administered survey. The study will monitor the proportion of participants who start HCV treatment within 12 weeks after testing positive for HCV RNA. Researchers will also link survey data to health records to assess long-term impacts of expanded HCV testing and treatment. This approach aims to improve diagnosis rates and support efforts to reduce HCV-related health burdens.

Researchers are evaluating a new combination treatment of Sigvotatug Vedotin plus pembrolizumab compared to pembrolizumab alone in adults with non-small cell lung cancer (NSCLC) that has high levels of PD-L1 protein. This study focuses on participants with advanced or metastatic NSCLC (Stage 3 or 4) who have PD-L1 expression in at least 50% of their tumor cells. The purpose is to understand how well the combination works versus pembrolizumab alone as a first treatment option. All participants receive pembrolizumab through an intravenous infusion once every 6 weeks at the study clinic. Half of the participants will also receive Sigvotatug Vedotin as an intravenous infusion every 2 weeks along with pembrolizumab. Participants may continue pembrolizumab treatment for up to about two years, while those receiving Sigvotatug Vedotin can continue until their cancer no longer responds to the treatment. During the study, participants will have regular clinic visits where researchers monitor their health and response to treatment. The main outcomes measured include overall survival up to approximately two years and progression-free survival, which tracks the time until cancer worsens or death. Safety and side effects will be closely observed throughout the study period to understand the treatments' impact.