Ieper

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 investigating the safety and effectiveness of eloralintide compared to a placebo in adults with persistent obesity or overweight. This includes people with or without type 2 diabetes who are already on stable weekly incretin therapy. The study is a phase 3, randomized, double-blind trial focusing on this specific group to better understand treatment outcomes. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once a week. The study compares these two treatments over the course of the trial. Participants must continue their stable incretin therapy throughout the study period. The study lasts about 80 weeks in total. Researchers will monitor changes in body weight from the start of treatment to week 64 as the main outcome. Participants will have regular assessments to track their health, safety, and treatment effects during this time.

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 safety, tolerability, pharmacokinetics, and effectiveness of surovatamig given by subcutaneous injection in adults with primary membranous nephropathy (pMN). Participants must be positive for anti-PLA2R antibodies and have significant, ongoing proteinuria, which places them at high risk of progressing to end stage kidney disease. This open-label Phase II study is conducted across 30 to 40 sites in about 10 countries. The study has two parts, each including three periods: screening, treatment, and follow-up, lasting up to 26 months in total. Participants will receive surovatamig by subcutaneous injections during the treatment periods. The study includes a multiple ascending dose design with sentinel dosing in Part A and multiple ascending doses in Part B. Participants will be closely monitored throughout the study with safety and tolerability assessments, pharmacokinetic measurements, and evaluation of proteinuria changes at 6 months. Researchers will track adverse events over an average of 2 years. Follow-up visits will assess ongoing health and kidney function to understand the long-term effects of the treatment.

Researchers are evaluating the effects of felzartamab in adults with Immunoglobulin A nephropathy (IgAN), a kidney disease caused by the buildup of abnormal IgA antibodies in the kidneys. This buildup leads to inflammation and damage, causing protein to appear in the urine. The study aims to understand how felzartamab influences proteinuria and kidney function, while also assessing the safety and how the body processes this treatment. This is a Phase 3, randomized, double-blind, placebo-controlled study focusing on adults with IgAN. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous (IV) infusions. Neither the participants nor the researchers will know which treatment is given. The treatment period lasts 24 weeks followed by an 80-week follow-up period. In total, participants will attend 17 study visits over about 2 years to receive infusions and participate in study activities. During the study, participants will undergo assessments including urine tests to measure protein levels, kidney function evaluations, and safety monitoring. Researchers will track changes in proteinuria from the start of the study to Week 36 as the main outcome. Additional measurements will include kidney function, clinical endpoints, and the study of how felzartamab is processed by the body. Participant safety and long-term effects will be monitored throughout the study and follow-up periods.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are evaluating how coronary function tests are used in routine clinical practice across multiple centers in Belgium. These tests include bolus thermodilution measurements to assess coronary microvascular function and invasive vasoreactivity tests using acetylcholine to detect coronary artery vasospasm. The study aims to determine how often these tests are performed, the reasons for their use, and the frequency of coronary microvascular dysfunction and coronary artery vasospasm among patients. Participants undergo coronary function tests as part of their clinical care, which may involve intracoronary bolus thermodilution and/or acetylcholine-induced vasoreactivity assessments. There are no additional study visits required beyond standard care. Patients may optionally complete questionnaires regarding their anginal symptoms and quality of life to provide more information. Data collected from each participant include medical history, cardiovascular risk factors, results from non-invasive tests, procedural details, and follow-up information from routine inpatient visits. Researchers will monitor the frequency of coronary microvascular dysfunction and coronary artery vasospasm over a five-year period. The study does not interfere with patient care and focuses on real-world clinical data collection and long-term follow-up.

Researchers are evaluating a structured rehabilitation pathway called the R³ pathway for patients undergoing lumbar surgery due to radicular pain, such as lumbar radiculopathy and radicular low back pain. This multicenter cluster randomized controlled trial compares the R³ pathway to usual care, aiming to see if this approach can reduce the time it takes for patients to return to work after surgery. The study focuses on a person-centered rehabilitation that supports patients through pre-, peri-, and postoperative phases while promoting early activity and work resumption. The R³ rehabilitation pathway involves a case manager guiding patients from before surgery up to one year after surgery. It includes prehabilitation, perioperative care, and postoperative rehabilitation emphasizing minimal activity restrictions, eliminating the use of braces, and active encouragement to resume work early. Hospitals participating in the trial are randomly assigned to either implement this pathway or continue with their usual care methods. The pathway specifically targets fear reduction and structured support to improve recovery. Participants will be monitored from surgery through 15 months postoperatively, with the main outcome being the time it takes to return to work. This involves regular assessments throughout the year following surgery to evaluate recovery progress and work reintegration. The study includes ongoing follow-up to understand the impact of the rehabilitation pathway compared to standard care on patient outcomes related to work and recovery.

Researchers are studying women who recently had gestational diabetes (GDM) and still show signs of glucose intolerance shortly after giving birth. These women are at high risk of developing type 2 diabetes (T2DM), with about half expected to develop it within five years. The study aims to see if the drug semaglutide, a long-acting GLP-1 agonist known for lowering blood sugar, reducing weight, and protecting the heart, can lower the risk of developing T2DM in these women compared to a placebo. This is a phase 3, multi-center, double-blind randomized controlled trial conducted in Belgium. Women 6 to 24 weeks postpartum with a history of GDM and glucose intolerance will be randomly assigned to receive either semaglutide or a placebo once weekly via injection. The semaglutide dose will be increased over eight weeks to a maintenance dose of 1 mg per week. Participants will also receive lifestyle guidance and be followed for three years. After stopping the intervention, they will undergo a 75g oral glucose tolerance test within 3 to 6 months. The study also groups participants based on their body mass index at early postpartum. Participants will be regularly assessed through blood tests measuring fasting glucose, oral glucose tolerance, and HbA1c to track diabetes development up to 160 weeks. Secondary measures include the need for diabetes rescue therapy, return to normal blood sugar levels, weight changes, and other metabolic functions. Safety and compliance will be monitored throughout the study to ensure participant well-being over the total study duration.

Researchers are collecting data in Flanders on how often suicide attempts and suicidal thoughts occur across various healthcare settings like hospitals, psychiatric centers, crisis teams, and general practitioners. The study aims to understand the methods used in suicidal behavior and see how many people receive proper aftercare following a suicide attempt. It uses a detailed tool called the Guideline for Suicide Care and Evaluation (LOES) to gather comprehensive information about individuals with suicidal thoughts or behaviors. The study includes a two-part semi-structured interview conducted by trained healthcare professionals such as nurses, psychologists, and psychiatrists. The first part happens shortly after admission to a healthcare facility following a suicide attempt or suicidal thoughts and collects demographic data, history, social support, hopelessness levels, and current suicidal ideation. The second part explores psychological factors more deeply, including motives, personal and interpersonal problems, and current thoughts of self-harm or suicide. Participants undergo detailed assessments on the first day covering demographics, clinical details, suicidal behavior methods, emotional state, suicidal intent and planning, past self-harm, social support, mental health history, substance use, coping strategies, and care needs. The study tracks participants’ openness to help and care pathways to formulate well-supported risk assessments. This comprehensive evaluation helps understand suicidal processes and needs in the Flanders region.