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Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effectiveness and safety of icotrokinra in adults with moderately to severely active Crohn's disease, a chronic condition causing severe inflammation in the intestinal tract. This Phase 2b/3 study aims to understand how well icotrokinra works compared to a placebo in improving symptoms and intestinal healing in this patient group. Participants will receive either icotrokinra or a matching placebo orally every day. The study includes both induction and maintenance phases where researchers assess clinical and endoscopic responses at specific time points, such as Week 12 and Week 40, to determine treatment effects over time. Throughout the study, participants will undergo various assessments including clinical evaluations, endoscopic exams, and safety monitoring. Researchers will measure outcomes like clinical response, clinical remission, and endoscopic healing at Weeks 12 and 40. The study involves regular monitoring to track the participants' health and treatment adherence over the duration of the trial.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the effectiveness of icotrokinra (JNJ-77242113) compared to a placebo in adults with active psoriatic arthritis (PsA). This study includes both participants who have previously used biologic treatments and those who have not. The goal is to assess how well the drug reduces the signs and symptoms of PsA by the 16th week of treatment. This is a Phase 3, multicenter, randomized, double-blind clinical trial designed to provide reliable evidence on the drug's impact on this condition. Participants will receive either icotrokinra or a placebo. The treatments will be administered according to the study protocol, but specific dosing details are not provided. Participants will be monitored over 16 weeks to evaluate their response to the treatment, focusing on the American College of Rheumatology (ACR) 20 response, which measures improvement in disease activity. The study compares the active drug against placebo to determine its efficacy and safety in this patient group. During the study, participants will undergo assessments to monitor their psoriatic arthritis symptoms, including joint swelling and tenderness, as well as blood tests to measure inflammation markers like C-reactive protein. Female participants who can become pregnant will have pregnancy tests before and during the study to ensure safety. Researchers will collect data on disease activity and safety throughout the study period to understand the treatment's effects. Total participation time and additional follow-up details are not specified.

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 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 evaluating etelcalcetide in children aged 28 days to under 18 years who have secondary hyperparathyroidism (SHPT) and chronic kidney disease (CKD) while on hemodialysis. SHPT is a serious condition that develops early in CKD and worsens as kidney function declines, leading to bone problems, growth issues, and higher cardiovascular risks in children on dialysis. Current treatments like vitamin D sterols can sometimes worsen complications, so this phase 3 trial aims to assess etelcalcetide's safety and effectiveness in this pediatric population, building on its approval and use in adults with SHPT on hemodialysis. The study compares etelcalcetide treatment to standard care, which may include vitamin D sterols, calcium supplements, and phosphate binders. Etelcalcetide is given as a drug to control intact parathyroid hormone (iPTH), calcium, and phosphorus levels. The trial is randomized, open-label, and controlled, with multiple dosing to evaluate efficacy, safety, and related pharmacokinetics and pharmacodynamics. Participants continue on their hemodialysis regimen with stable dialysate calcium levels throughout the trial. Participants will have screenings and assessments including laboratory tests for iPTH, calcium, and phosphorus levels, as well as ECG monitoring and other safety evaluations. The primary outcomes measure the percentage of participants achieving at least a 30% reduction in mean iPTH from baseline during weeks 20 to 27. The study monitors participants closely for adverse effects and treatment response over the trial period to gather critical pediatric data on etelcalcetide's use in this vulnerable group.

Researchers are evaluating an early switch from intravenous (IV) to oral antibiotic treatment for patients with uncomplicated Staphylococcus aureus bloodstream infection (bacteraemia). This phase 3, multicenter, randomized, open-label trial compares the safety and effectiveness of early oral antibiotic therapy against the standard minimum 14-day course of IV antibiotics in patients considered low-risk for complications. The study involves 290 patients from 12 Malaysian tertiary hospitals who have received 3 to 7 days of IV antibiotics. Participants are randomly assigned to either continue standard IV antibiotic treatment or switch early to oral antibiotics, including options like trimethoprim-sulfamethoxazole, clindamycin, cephalexin, or linezolid. The choice of antibiotic depends on bacterial susceptibility and patient factors. The treatment phase lasts 7 to 11 days, followed by a 90-day follow-up period with scheduled phone or inpatient visits. During the approximately 12-week study, patients undergo screening and enrollment, receive open-label antibiotic treatment, and are monitored at days 7-11, 30, and 90 after randomization. Researchers assess outcomes such as the rate of relapse of Staphylococcus aureus bacteraemia within 90 days. Patient condition reviews and standard clinical assessments are conducted to ensure safety and measure treatment effectiveness.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.