Ieper

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Researchers are evaluating eloralintide, a drug given once weekly, in adults who have persistent obesity or are overweight, including those with or without type 2 diabetes. The study focuses on people who are already on stable incretin therapy, aiming to compare the effects and safety of eloralintide to a placebo over about 80 weeks. This phase 3 trial is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive one of four different doses of eloralintide or a placebo, all administered by subcutaneous injection. The treatment period involves weekly dosing, continuing through the study duration. The study uses a double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. The main goal is to measure changes in body weight from the start to week 64, along with other health indicators. Throughout the study, participants will undergo various assessments including measurements of waist circumference, blood pressure, fasting glucose, insulin levels, and inflammatory markers. They will also complete questionnaires about their quality of life and eating behaviors. Researchers will monitor medication use and drug levels in the body to understand how eloralintide behaves. The total participation time is about 80 weeks, with safety and efficacy evaluations at regular intervals.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of surovatamig, given by subcutaneous injection, in adults with primary membranous nephropathy pMN who have anti-PLA2R antibodies and persistent heavy proteinuria. This Phase II open-label study focuses on patients at high risk of progressing to end-stage kidney disease and is conducted across 30 to 40 sites in about 10 countries. The study includes two parts with multiple dosing schedules to assess the treatment thoroughly. Participants will receive surovatamig by injection during the treatment periods. The study consists of two parts Part A with multiple ascending doses and sentinel dosing, and Part B with multiple ascending doses. Each part includes a screening period, a treatment period, and a follow-up period, with the total study duration lasting up to 26 months. Participants receive the investigational drug and are monitored throughout these stages. During the study, participants will undergo various assessments including urine protein measurements, anti-PLA2R antibody levels, B-cell counts, and patient-reported symptom experiences. Safety is monitored by tracking adverse events throughout the study, which lasts on average two years. Pharmacokinetic measures, such as plasma concentration levels of surovatamig, and immunogenicity evaluations are also included. Regular visits will support ongoing evaluation of treatment effects and participant health.

Researchers are studying felzartamab in adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by abnormal IgA antibodies building up in the kidneys leading to inflammation and damage. This Phase 3 clinical trial aims to understand how felzartamab affects proteinuria, the presence of protein in urine, and kidney function in people with IgAN. The safety and how the body processes felzartamab are also being evaluated. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusions during a 24-week treatment period. Some participants with lower kidney filtration rates will be grouped separately but also receive either felzartamab or placebo. After treatment, participants will enter an 80-week follow-up phase. In total, participants will have 17 study visits over about two years. Throughout the study, participants will have urine tests to measure proteinuria, blood tests to assess kidney filtration function, and monitoring for side effects. Researchers will also study felzartamab levels in the blood and check for immune reactions against the drug. Safety will be closely monitored using vital signs, laboratory tests, and physical exams during the entire 104-week period.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are conducting a prospective, multicenter registry to observe the real-world use of coronary function tests in routine Belgian medical practice. These tests may include bolus thermodilution measurements of coronary microvascular function and invasive vasoreactivity tests using acetylcholine. The study aims to understand how often these tests are performed, the reasons for testing, and the frequencies of coronary microvascular dysfunction and coronary artery vasospasm. Participants scheduled for coronary function tests will have data collected from their medical records regarding cardiovascular risk factors, past medical history, non-invasive test results, procedural details, and follow-up visits. There are no study-specific visits planned. Optionally, participants may complete questionnaires about their anginal symptoms and quality of life. No interventions are administered as part of this observational study. Participants involvement includes routine data collection from medical files over a follow-up period of up to five years. Researchers will measure the frequency of coronary microvascular dysfunction and coronary artery vasospasm, as well as describe predictors for these conditions and major adverse cardiovascular events over one and three years among different patient groups. The study is organized by the University Hospital, Antwerp, and aims to provide valuable insights into coronary function testing practices and outcomes.

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.

Researchers are comparing outcomes and complications between two types of medial unicompartmental knee prostheses used in knee surgery fixed bearing FB and mobile bearing MB designs. The study focuses on adults aged 50 to 80 with medial gonarthrosis. The FB design is simpler to implant but may wear out earlier, while the MB design may improve joint movement and load distribution but carries risks of insert dislocation and fractures. MB implants can also be cementless, potentially reducing surgery time and cement-related issues. Participants will receive either a mobile or fixed unicompartmental knee prosthesis. The study will measure various clinical and radiological outcomes, including surgery time, complications, and revision rates within two years after surgery. The study will assess outcomes such as the Oxford Knee Score OKS, Arthrogenic Muscle Inhibition AMI, pain scales, and quality of life questionnaires at several time points up to 24 months postoperatively. Participants will be evaluated before surgery and at multiple follow-up visits at 6 weeks, 4 months, 12 months, and 24 months after surgery. Assessments include clinical exams, imaging for bone and joint condition, and questionnaires on pain and function. The study tracks complications, any need for revision surgery, and muscle inhibition to understand the differences in performance and safety between the two prosthesis types over two years.