Subang Jaya

Immunoglobulin A nephropathy (IgAN) is a kidney disease caused by the build-up of immune protein complexes in the kidneys, leading to inflammation and possible kidney damage. This Phase 3 study is evaluating how well mezagitamab, compared to a placebo, reduces protein levels in the urine (proteinuria) in adults with primary IgAN. It also aims to assess the safety and tolerability of mezagitamab and its ability to maintain kidney function over the long term. Participants will be randomly assigned to one of two groups in the main study: two-thirds will receive mezagitamab injections under the skin, and one-third will receive placebo injections that look identical but have no active medicine. Treatment will occur in two 1-year cycles, each including about six months of dosing and six months of observation with monthly check-ups. An open-label group will include a small number of participants with lower proteinuria or kidney filtering issues, including those who previously received mezagitamab in another study; these participants will receive mezagitamab similarly to the main group. During the study, participants will visit the clinic several times for assessments. Researchers will monitor changes in proteinuria from the start through week 36, along with safety and kidney function. They will also perform regular evaluations and check-ups throughout each treatment and observation period to track participants' health and response to treatment.

Researchers are evaluating the effects of a medicine called BI 764198 in adults and adolescents aged 12 years and older who have a kidney condition known as focal segmental glomerulosclerosis (FSGS). This Phase 3 study aims to understand whether BI 764198 can improve kidney health in people with primary FSGS or genetic FSGS related to TRPC6 gene variants by comparing changes in urine protein levels over 104 weeks. Participants are randomly assigned to one of two groups: one group takes BI 764198 tablets once daily, and the other group takes placebo tablets that look like the medicine but contain no active drug. All participants continue their usual FSGS treatments during the study, which lasts up to two years. During the study, participants visit the study site approximately every three months. They regularly provide urine samples to monitor kidney function, and doctors check their overall health and note any side effects. The main outcome measured is the change in the 24-hour urine protein-to-creatinine ratio from the start of the study to week 104, helping researchers understand the treatment's impact on kidney disease.

Researchers are studying children and young adults aged 1 to 18 years with chronic kidney disease (CKD) and proteinuria, a condition where the kidneys leak protein into the urine. The study aims to understand the safety of a treatment called finerenone when used together with standard medicines called ACE inhibitors or angiotensin receptor blockers (ARBs). These medicines help control kidney function and blood pressure by targeting a system called the renin-angiotensin-aldosterone system (RAAS), which is often overactive in CKD. Finerenone may help control this system more effectively alongside ACEI or ARB. Participants will receive finerenone in doses adjusted by age and body weight for up to 18 months. The study is open-label and single-arm, meaning all participants receive the treatment. Some participants already took finerenone in a previous study and will continue, while others will start anew. The treatment period lasts about 540 days with a 1-month follow-up after the last dose. Visits are planned at least 12 times for new finerenone users and 8 times for continuing users. During visits, participants will have their blood pressure, heart rate, temperature, height, and weight measured. Blood and urine samples will be collected to monitor kidney function and protein levels. Heart function will be checked using electrocardiograms and echocardiography. Participants and their guardians will answer questions about medication use, side effects, and well-being. Researchers will track any medical problems during the study and check health about 30 days after treatment ends. The main focus is safety, including monitoring adverse events, potassium levels, and blood pressure changes over about 19 months.

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

Researchers are investigating a new treatment approach for children aged 6 months to less than 18 years who have chronic kidney disease (CKD) and proteinuria, a condition where the kidneys leak protein into the urine. CKD causes the kidneys to work less effectively, leading to waste buildup and high blood pressure. Current treatments include ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB), which help regulate a system involved in blood pressure and kidney function. However, these treatments do not work for all patients. This study is focused on seeing if adding finerenone to ACEI or ARB can better control this system and improve kidney function. Participants will receive either finerenone or a placebo for about 180 days, alongside their usual ACEI or ARB medication. The study will adjust finerenone doses based on age and body weight. Before starting treatment, participants will attend up to two screening visits within 104 days to check eligibility. During the treatment phase, participants will make at least seven visits to the study site for ongoing care and monitoring. Throughout the study, doctors will measure participants' blood pressure, heart rate, temperature, height, and weight. They will collect blood and urine samples to monitor kidney function and protein levels. Heart health will be checked using electrocardiograms and echocardiography. Participants or their parents will answer questions about medication use, side effects, and how they feel. Researchers will track any medical problems that occur during the study and will follow up about 30 days after treatment ends. The main goal is to see how much the protein in urine changes from the start to day 180.

Researchers are studying an experimental drug called odronextamab in combination with lenalidomide for adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL), which are subtypes of Non-Hodgkin's lymphoma. This Phase 3 study has two parts: Part 1 focuses on the safety and tolerability of this drug combination and determining the appropriate odronextamab dose, while Part 2 compares the effectiveness of this combination to the current standard treatment of rituximab plus lenalidomide. The study also explores side effects, drug levels in the blood, antibody development against the study drug, and impacts on quality of life and daily activities. Participants receive either odronextamab plus lenalidomide or rituximab plus lenalidomide according to the study protocol. Part 1 is not randomized, focusing on safety and dose finding, while Part 2 is randomized and controlled to assess efficacy and safety. Treatments are administered per protocol guidelines during these study phases. During the study, participants undergo regular evaluations including imaging scans to measure disease, blood tests, and monitoring for side effects up to two years. The main outcomes measured include dose-limiting toxicities within 35 days, treatment-emergent adverse events over two years, and progression-free survival over five years. Participants are also monitored for quality of life and ability to perform daily activities throughout the trial duration.

Researchers are evaluating the feasibility and preliminary impacts of iSupport-Malaysia, an online program designed to support informal caregivers of people living with dementia in Malaysia. This pilot randomized controlled trial aims to compare the web-based iSupport-Malaysia intervention with its eBook version, focusing on caregiver psychological well-being, including burden, depression, anxiety, stress, and quality of life. The study also explores user perceptions regarding the usability and usefulness of the program. Participants will be randomly assigned to either the iSupport-Malaysia website or the eBook, both culturally adapted and delivered in the Malay language. The web version includes 23 lessons across 5 modules with videos, quizzes, and reflection exercises, while the eBook contains the same content in text-based format with quizzes and worksheets. Participants are encouraged to complete at least 10 lessons over a 3-month period, with reminders sent every two weeks. After the intervention, both groups gain access to both formats, and selected web group participants will take part in interviews about their experience. During the study, assessments on psychological well-being will be conducted online at baseline, 1 month, and 3 months. Researchers will monitor recruitment, randomization, retention, and program engagement rates. Participants' adherence is tracked via self-reports on usage frequency, lesson completion, and time spent. The study lasts 3 months per participant, with data collected through secure online platforms and follow-up interviews to understand user satisfaction and program impact.

Researchers are evaluating neladalkib (NVL-655) compared to alectinib in patients with treatment-naefve, ALK-positive advanced Non-Small Cell Lung Cancer (NSCLC). This Phase 3, multicenter, randomized, controlled, open-label study aims to show that neladalkib can prolong progression-free survival (PFS) better than alectinib in this patient group. Patients included have advanced or metastatic NSCLC confirmed to have ALK rearrangement and have not received prior systemic anticancer treatments for NSCLC. Participants will be randomly assigned in a 1:1 ratio to receive either oral neladalkib tablets or oral alectinib capsules. Each group will have approximately 225 patients. Treatment will be given as first-line therapy without prior ALK tyrosine kinase inhibitor use. The study monitors the patients over time to compare the effectiveness of these two drugs in controlling the disease. During the study, researchers will assess progression-free survival up to 5 years after the first patient is dosed, using blinded independent central review. Patients will have measurable disease and provide pretreatment tumor tissue for evaluation. Safety monitoring includes tracking heart rhythm, infections, and other health conditions. The study excludes patients with certain infections, recent major surgery, or other active cancers requiring therapy. This comprehensive follow-up aims to evaluate how well each treatment controls cancer progression and its safety over time.

Researchers are evaluating a school-based program aimed at improving mental health among adolescents aged 12 to 14 years who are at risk due to moderate to severe anxiety or depression. This study focuses on youth from low-income communities in both rural and urban areas of Malaysia. The trial uses a two-arm, cluster randomized controlled design to compare the effects of the mental health-focused intervention against a control condition, with assessments at several points including before the intervention, immediately after, and at six and twelve months later to measure changes in anxiety, depression, and wellbeing. The study compares two group-based programs delivered by school staff over eight weekly sessions lasting 45 to 60 minutes each. The intervention group participates in the "Super Skills for Life" (SSL) program, designed to reduce anxiety and depression and improve mental wellbeing. The control group participates in a Study Skills Programme (SSP) teaching note-taking, effective study strategies, and time management. Classrooms are randomly assigned to one of the two programs, and eligible adolescents within each class receive the assigned intervention. Participants complete questionnaires including the Depression Anxiety and Stress Scale-21 (DASS-21) at screening, baseline, post-intervention, and follow-ups at six and twelve months. Researchers monitor changes in anxiety, depression, and wellbeing as primary outcomes. The study also aims to evaluate the cost-effectiveness of the program and understand factors that influence its success in Malaysian schools. In total, 428 adolescents are expected to take part, contributing to a comprehensive evaluation of these school-based mental health supports.