Klaipeda

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

Researchers are evaluating the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis, a chronic autoimmune disease. This phase 2, randomized, double-blinded, placebo-controlled study aims to assess how well the treatment works and its safety profile. Participants have systemic sclerosis with specific skin involvement and meet classification criteria, with the study sponsored by argenx. Eligible participants will be randomly assigned in a 21 ratio to receive either subcutaneous efgartigimod PH20 SC or a placebo, both given by prefilled syringe. The treatment period lasts up to 48 weeks, followed by a safety follow-up period. The total duration of the study can be up to approximately 15 months, including screening, treatment, and follow-up. Participants will undergo screening to confirm eligibility and then receive regular doses of the study drug or placebo during the treatment phase. Assessments include changes in skin thickness measured by the modified Rodnan Skin Score mRSS at 24 and 48 weeks, safety monitoring for adverse events, and evaluations of disability, patient and clinician assessments, lung function, and antibody levels. The study also tracks pharmacokinetics, immunogenicity, and antibody responses throughout the treatment and follow-up periods.

Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

This research aims to evaluate the safety, effectiveness, and how the body processes ferumoxytol for treating iron deficiency anemia IDA in children aged 2 to under 18 years. The study includes male and female pediatric subjects with IDA or those considered at risk of developing IDA by their clinician, regardless of cause, except for those with chronic kidney disease CKD, who are studied separately. Participants will be randomly assigned in a 21 ratio to receive either ferumoxytol or iron sucrose. Ferumoxytol is given as two intravenous doses of 7 mg iron per kg, with a maximum of 510 mg per dose the first dose is on Day 1 and the second dose is 2 to 8 days later. Iron sucrose is given as five intravenous doses of 4 mg iron per kg, with a maximum of 200 mg per dose the first dose is on Day 1 and the remaining doses are given at least once per week and up to three times per week. Participants are monitored for one hour after each infusion. Throughout the study, which lasts up to 5 weeks, researchers will assess hemoglobin levels, check for side effects or adverse events, and perform other safety tests. The main outcome measured is the change in hemoglobin from the start to Week 5. Additional safety assessments include tracking any new or special adverse events up to 49 days after treatment begins.

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of ferumoxytol compared to iron sucrose in children with chronic kidney disease CKD who have iron deficiency anemia IDA or are at risk of developing it. The study focuses on pediatric patients aged 2 to under 18 years and aims to better understand ferumoxytols profile in this group. This Phase 3, randomized, open-label study involves multiple centers and approximately 125 participants. Participants will be randomly assigned in a 21 ratio to receive either ferumoxytol or iron sucrose. Those in the ferumoxytol group will get two intravenous infusions of 7.0 mg Fekg up to 510 mg per dose, the first on Day 1 and the second 2 to 8 days later. Those receiving iron sucrose will have dosing based on dialysis status hemodialysis-dependent patients receive 2 mg Fekg on consecutive dialysis sessions for 10 doses, and non-hemodialysis-dependent or peritoneal dialysis-dependent patients receive 4 mg Fekg up to three times per week for 5 doses, with total maximum doses capped at 1000 mg. The study lasts up to 7 weeks, including a 2-week screening period and a 5-week treatment period. Researchers will monitor hemoglobin changes, adverse events, and special safety concerns during 49 days of follow-up. Assessments include blood tests to measure hemoglobin and iron levels, safety evaluations, and pharmacokinetic and pharmacodynamic analyses. This helps determine how participants respond and tolerate the treatments over time.

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. This study aims to evaluate the long-term safety of finerenone when added to standard treatments called ACE inhibitors or angiotensin receptor blockers ARBs, which are commonly used to control blood pressure and protect kidney function. The research also seeks to understand how well finerenone can reduce protein levels in urine and support kidney health over time. Participants will receive finerenone in doses adjusted by age and body weight, taken orally for up to 18 months alongside their usual ACEI or ARB treatment. The study includes patients who previously took part in a related trial and will follow them for about 19 months, including a one-month follow-up after treatment ends. The research involves one group receiving finerenone openly without placebo or comparison groups. During the study, participants will attend at least 8 to 12 visits depending on their treatment start status. At these visits, doctors will measure vital signs like blood pressure, heart rate, weight, and height perform physical exams collect blood and urine samples to monitor kidney function and protein levels and conduct heart tests using electrocardiograms and echocardiography. Participants and their caregivers will also answer questions about medication use, side effects, and overall well-being. Safety will be closely monitored by tracking any medical problems that arise during the trial.

Researchers are investigating a new treatment approach for children with chronic kidney disease CKD and proteinuria, conditions that affect kidney function and cause protein leakage into the urine. The study focuses on whether adding a drug called finerenone to existing treatments with angiotensin-converting enzyme inhibitors ACEI or angiotensin receptor blockers ARB can better control kidney problems related to overactivity of a system that regulates blood pressure and fluid balance. This Phase 3 study aims to see if finerenone can reduce protein levels in the urine more effectively than a placebo. Participants in this trial will receive either finerenone or a placebo alongside their usual ACEI or ARB medication. The study treatment lasts about 180 days, with doses adjusted for age and body weight. Before starting treatment, children must pass screening visits to confirm eligibility. During treatment, participants will attend at least seven visits where various health checks, blood and urine tests, heart exams, and questionnaires about medication experience and side effects will be performed. Throughout the study, researchers will monitor kidney function, electrolyte levels, and how the body processes finerenone. They will also track any medical problems participants experience. After completing treatment, participants will have a follow-up visit about 30 days later to assess their health. The main measure of success is the change in the urinary protein-to-creatinine ratio from before treatment to about six months later, helping to understand the treatments impact on proteinuria.

Researchers are evaluating the ContraBand12 device, a transcatheter constriction implant placed in the left and right branch pulmonary arteries to treat left-sided heart failure. This early feasibility study aims to assess how the device reduces pulmonary artery pressure and improves heart function during exercise, potentially enhancing physical capacity and prognosis for heart failure patients. The study is prospective, multi-center, interventional, open-label, and single-arm, focusing on safety and device feasibility. The intervention involves percutaneous implantation of the ContraBand devices through right heart catheterization. The device works by locally narrowing the pulmonary arteries, which lowers distal systolic pulmonary artery pressure and reduces the rise in pulmonary capillary wedge pressure during exercise. This change reflects improved left ventricular filling and cardiac output. There is no comparator group all participants receive the ContraBand implant. Participants will be monitored for device- or procedure-related major adverse events within 30 days and procedural success during implantation. Assessments include six-minute walk test distance and heart function measures. The study enrolls adults aged 18 to 85 with symptomatic left heart failure, and participants will be followed for safety and functional outcomes. The total study duration extends up to the end date in 2032, with detailed follow-up to evaluate feasibility and safety.

Researchers are examining the feasibility of implementing digitally supported physical rehabilitation for cancer patients during and after systemic treatment. This multinational study involves five countries in the South Baltic region and aims to improve accessibility to rehabilitation services, which are important for maintaining physical function and quality of life in cancer survivors. The study addresses barriers such as distance to facilities, busy treatment schedules, and limited internet access, with the goal of enhancing rehabilitation reach and sustainability across different healthcare settings. The intervention consists of needs-based digital rehabilitation programs lasting from 8 to 16 weeks, delivered by trained healthcare professionals. Each participating site selects a digital solution tailored to local needs, offering either fully or partially digital rehabilitation during systemic cancer treatment and after treatment completion. The study includes two separate feasibility trials one for patients currently receiving systemic therapy and another for those who have recently completed treatment or are on maintenance therapy. Participants will engage in individualized goal setting and rehabilitation guided by healthcare professionals, with assessments conducted throughout the intervention period. Data collection includes patient-reported outcomes, therapist perspectives, and resource use, all stored securely in a database. The study will measure factors such as reach, effectiveness, adoption, implementation, and maintenance of digital rehabilitation using the RE-AIM framework. Safety, drop-outs, and economic aspects will also be monitored over approximately 4 to 12 weeks for patients and up to about one year for therapists.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.