Aveiro

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are evaluating the effectiveness, safety, and tolerability of mavorixafor in people aged 12 and older who have congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders. These participants experience repeated and/or serious infections due to low neutrophil levels. The study aims to show clinical benefit by increasing circulating neutrophils and reducing infection rates. Participants will continue their existing treatments, which may include granulocyte-colony stimulating factor (G-CSF), immunoglobulin replacement, prophylactic antibiotics, or observation without active treatment. They will be randomly assigned to receive either mavorixafor or a placebo, with both drugs given according to a set schedule. The study is double-blind and placebo-controlled, conducted across multiple centers. During the study, researchers will monitor participants for up to 52 weeks, focusing on the annual infection rate and the number of participants achieving a positive response in absolute neutrophil count. Participants will undergo regular assessments, including blood tests to measure neutrophil levels and evaluations for infections. The study includes safety monitoring and requires participants to maintain stable doses of their background therapies unless safety concerns arise.

Researchers are evaluating the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment for reversing anticoagulation in adults treated with Factor Xa inhibitors who need urgent surgery or invasive procedures. This Phase 3 trial aims to assess the safety and effectiveness of TAK-330 in managing direct oral Factor Xa inhibitor-related coagulopathy in this urgent setting. Participants will be randomly assigned to receive either TAK-330 or the standard care 4F-PCC before their surgery. TAK-330 is given as a single intravenous infusion of 25 IU/kg on Day 1, with a possible additional dose if needed. The standard 4F-PCC dosing and infusion speed follow local protocols, with an option for an extra dose not exceeding 50 IU/kg or 5,000 IU during surgery if required. During the study, participants will be hospitalized for surgery and monitored closely. Researchers will assess the effectiveness of stopping bleeding during surgery and follow up with participants by telehealth or phone call 30 days after surgery. The study will track safety and hemostasis to understand the impact of the treatments on bleeding control and patient outcomes.

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 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.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Researchers are evaluating the safety and effectiveness of the Hydrustent4 biodegradable hydrogel ureteral stent in adults with urinary lithiasis (kidney or ureteral stones). This study compares Hydrustent4 to a standard polyurethane double loop ureteral stent to see if it can maintain urinary flow after surgery without causing additional medical problems. The study includes both an initial pilot phase to assess safety in 16 participants and a larger pivotal phase with 118 participants to confirm clinical performance and safety. Participants will receive either the Hydrustent4 biodegradable stent, which naturally degrades in the body and avoids the need for removal surgery, or the standard polyurethane stent known for good tolerance and resistance to encrustation. These devices are inserted after stone removal surgery using endourological techniques. The study involves two phases: the pilot phase focuses on initial safety and some efficacy results, while the pivotal phase gathers comprehensive data on safety and effectiveness. During the 3-month follow-up period, participants will attend regular visits for monitoring recovery. Researchers will collect data through questionnaires, imaging exams, blood and urine tests, and will track urinary drainage and adverse events from surgery up to day 28 post-treatment. The study aims to measure if Hydrustent4 maintains urine flow, prevents the need for additional surgery to remove the stent, reduces urinary symptoms, and is durable for at least 24 hours. Safety is closely monitored throughout the treatment period.

Hypertension is a leading preventable cause of cardiovascular disease and death worldwide. Resistant hypertension, a severe form where blood pressure remains high despite multiple medications, affects about 10-20% of people with hypertension. Researchers are investigating the safety and effectiveness of two types of isometric exercises—handgrip and wall squat—to see how they affect blood pressure in people with resistant hypertension. Participants will first attend an acclimatization session where study procedures are explained, data collected, and exercise intensity assessed. Then, each participant will complete three sessions in random order: a non-exercise control, an isometric handgrip exercise performed at 30% of maximum voluntary contraction, and an isometric wall squat performed at 95% of peak heart rate. Each exercise session involves four repetitions lasting two minutes each. During and after the sessions, blood pressure will be carefully monitored, starting 15 minutes after exercise and then every 20 minutes for up to 12 hours. The study aims to determine the safety of these exercises and compare their effects on lowering blood pressure. Participants are adults aged 40 to 75 years with stable resistant hypertension, and their blood pressure will be tracked closely throughout the study.

Living with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) presents significant daily challenges for patients and their informal caregivers, especially in advanced stages. These needs are often unmet by current disease-modifying treatments. Researchers are studying whether adding palliative care education to pulmonary rehabilitation (PR), a well-established treatment for chronic respiratory diseases, can improve knowledge about palliative care for people with COPD or ILD and their informal caregivers. The study compares two groups: one receiving traditional PR and the other receiving PR combined with palliative care education. Both groups participate in a 12-week program with twice-weekly supervised exercise sessions and weekly education and psychosocial support sessions. The experimental group also receives an education session on palliative care, peer-to-peer and get-apart sessions for personal discussions, and online sessions every two weeks. Individual cases may be referred to specialist palliative care or other health professionals based on specific needs. Participants provide data at the start, after 12 weeks (end of PR), and at 6 months post-PR. Assessments include health status, symptoms, quality of life, needs, knowledge about palliative care and the disease, and attitudes toward palliative care referral. Informal caregivers also report on their health, caregiving role, symptoms, burden, and knowledge. Qualitative data from focus groups are collected from the experimental group. The study aims to provide evidence on personalized PR with integrated palliative care education.

Researchers are investigating functional status in people with interstitial lung diseases (ILD), focusing on understanding how functional abilities decline, determining the reliability of tools measuring functional status, exploring patient perspectives, and developing a tool to predict mortality based on functional status. ILD is a group of chronic lung diseases causing inflammation and scarring, leading to reduced exercise capacity and muscle dysfunction, which significantly impacts daily activities and quality of life. The study aims to identify different patterns of functional decline and improve mortality predictions beyond existing models. The study is observational and multicentric, involving multiple healthcare centers. It includes four main tasks: validating functional status measurement tools with assessments at baseline and one week later; conducting interviews to understand patient perspectives; following participants every six months for two years to observe functional status progression and mortality; and developing a multidimensional index to predict mortality. Each assessment takes about 90 minutes and includes collecting clinical, demographic, and functional data. Participants will undergo evaluations at six time points: baseline, one week after baseline, and then every six months up to 24 months. Data collected includes muscle strength, physical activity, symptoms, and quality of life, alongside clinical records such as lung function and hospitalization history. Researchers will analyze changes over time and use interviews to gain qualitative insights. The primary outcome is the Short Physical Performance Battery measured across all visits to assess functional status changes.