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Found 14 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying whether ziltivekimab can help people living with heart failure and inflammation. The trial focuses on participants with heart failure who have mild to preserved heart function and systemic inflammation. This phase 3 study compares ziltivekimab, a new medicine not yet approved, to an inactive placebo to understand its effects on heart failure symptoms and physical function. Participants will receive either ziltivekimab or a matching placebo administered as a subcutaneous injection once a month for 12 months. Both groups will continue their standard heart failure care alongside the study treatment. The treatment assignment is randomized, meaning participants have an equal chance of receiving the active medicine or placebo, and the study uses a quadruple masking method to keep participants and researchers unaware of the treatment given. During the study, participants will be monitored for changes in heart failure symptoms using tools like the Kansas City Cardiomyopathy Questionnaire and a 6-minute walk test. Researchers will also assess inflammation markers, heart function measures, and quality of life at regular intervals over the 12 months. The study aims to observe the effects of ziltivekimab compared to placebo over this period, with safety and symptom improvement carefully tracked.
Actively Recruiting
Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk AS, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.
Actively Recruiting
This trial investigates the effectiveness of elacestrant compared to standard endocrine therapy for adults with node-positive, estrogen receptor-positive ER, HER2-negative early breast cancer who are at high risk of recurrence. The study aims to understand if elacestrant can improve outcomes in this group over standard treatments. Participants will be randomly assigned to receive either 345 mg of elacestrant once daily for five years or continue with their previous standard endocrine therapy, which may include anastrozole, letrozole, exemestane, or tamoxifen. Both treatments are taken orally, and the study is open-label, meaning participants and researchers know which treatment is given. During the study, participants will be monitored for up to five years for outcomes such as invasive breast cancer-free survival, distant relapse-free survival, overall survival, and quality of life changes. Assessments include questionnaires on health status and physical functioning, symptom evaluation, and blood tests to measure elacestrant levels. Safety and adverse events will be tracked throughout and for 28 days after treatment ends.
Actively Recruiting
Researchers are evaluating the efficacy and safety of obexelimab in adults with systemic lupus erythematosus SLE, a chronic autoimmune disease. This phase 2, randomized, double-blind study includes participants diagnosed with SLE for at least 24 weeks who meet specific disease activity criteria based on established lupus assessment scores. The study is sponsored by Zenas BioPharma USA, LLC and aims to better understand how obexelimab affects lupus symptoms and immune activity. The study involves a 24-week treatment period where participants receive either obexelimab or a placebo through weekly subcutaneous injections. Prior to treatment, a screening period up to 28 days confirms eligibility. After the treatment period, there is a 12-week follow-up phase. All participants continue their standard lupus care with nonbiologic therapies such as corticosteroids, antimalarials, or immunosuppressants. Scheduled visits occur at weeks 2, 4, and every 4 weeks thereafter during the treatment phase. During the study, participants will undergo assessments for lupus disease activity, safety, drug levels, immune responses, and potential side effects. These evaluations include clinical exams and laboratory tests at regular visits. The total duration of participation can last up to approximately 40 weeks, covering screening, treatment, and follow-up. Researchers will review primary and secondary outcome measures to assess the impact of obexelimab on lupus activity and patient health throughout the study.
Actively Recruiting
Researchers are evaluating DMX-200 repagermanium, a drug that blocks a receptor involved in inflammation, in patients with focal segmental glomerulosclerosis FSGS who are also receiving an angiotensin II receptor blocker ARB. This Phase 3 study aims to assess the safety and effectiveness of DMX-200 compared to placebo over two years in adults and adolescents aged 12 to 17 years. The study is led by Dimerix Bioscience Pty Ltd and includes a double-blind period followed by an open-label extension to observe long-term effects. Participants receive either 120 mg of DMX-200 or a matching placebo capsule twice daily for 104 weeks during the double-blind treatment phase. Afterward, those who complete this phase may enter a two-year open-label extension where all participants receive DMX-200 twice daily. The study includes a screening and qualification period lasting 6 to 14 weeks, a possible titration phase, a stabilization phase, and a follow-up period after treatments. Throughout the trial, patients will undergo assessments including urine proteincreatinine ratio and kidney function tests like estimated glomerular filtration rate eGFR at multiple time points up to week 104 and during the extension. Safety and tolerability are closely monitored through regular evaluations, adverse event tracking, and follow-up visits. Total participation may last about 230 weeks, covering all study phases and follow-up periods.
Actively Recruiting
Researchers are studying whether the medicine BI 764198 helps adults and adolescents with a kidney condition called focal segmental glomerulosclerosis FSGS. This study is a phase 3 clinical trial that compares BI 764198 with a placebo to understand its effects on kidney health in people with primary FSGS or genetic FSGS related to TRPC6 gene variants. The study is sponsored by Boehringer Ingelheim. Participants are randomly assigned to one of two groups one group takes BI 764198 tablets once a day, and the other takes placebo tablets that look like BI 764198 but contain no medicine. All participants continue their standard treatment for FSGS during the study. The treatment period lasts up to 104 weeks 2 years. Participants visit the study site about every three months during the two-year period. They regularly collect urine samples to monitor kidney function, and doctors assess their health and record any side effects. The main outcome measured is the change in urinary protein-to-creatinine ratio over 104 weeks. Other assessments include kidney filtration rate and treatment response. The study carefully monitors safety and treatment effects throughout.
Actively Recruiting
Researchers are studying the use of felzartamab for adults with Immunoglobulin A nephropathy IgAN, a kidney disease caused by buildup of abnormal IgA antibodies that damage kidney filters. The study aims to understand how felzartamab affects proteinuria, or protein in the urine, as well as kidney function, safety, and how the body processes the drug. This research is a Phase 3 randomized, double-blind, placebo-controlled trial. 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 function will receive treatment in separate cohorts. After treatment, there is an 80-week follow-up period. In total, participants will have 17 study visits over about two years. During the study, researchers will measure changes in urine protein levels, kidney filtration rates, and other clinical endpoints. They will also monitor felzartamab levels in the blood, immune responses, and any adverse events. Safety assessments include vital signs, lab tests, ECGs, and physical exams. The study tracks participants closely throughout treatment and follow-up to evaluate felzartamabs effects on IgAN.
Actively Recruiting
Researchers are evaluating the long-term safety and tolerability of pelacarsen TQJ230 in adults with established cardiovascular disease and elevated Lipoproteina who have completed a prior double-blind study. This open-label extension study follows participants from the parent trial CTQJ230A12301 to continue monitoring the effects of pelacarsen over an extended period. Participants will receive pelacarsen 80 mg once a month by subcutaneous injection during the open-label extension. This single-arm, multicenter study lasts up to 36 months, providing continued access to the study drug for those who completed the parent trial while still on the investigational product. During the study, participants will be regularly assessed for adverse events and cardiovascular outcomes, including major cardiovascular events tracked from both the parent study baseline and the extension study baseline. Lipoproteina levels will be measured at multiple time points to monitor changes over the course of the study. Safety and tolerability data will be collected up to 36 months, with ongoing monitoring by the research team throughout the study duration.
Actively Recruiting
Researchers are evaluating the effects of the medicine BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. This study includes people with or without type 2 diabetes and those who may or may not be taking certain blood pressure medicines such as ACE inhibitors or ARBs. The goal is to understand if adding BI 690517 to empagliflozin helps reduce the risk of kidney failure, heart disease, or hospitalization due to heart failure. The study has two parts. In the first part, all participants receive empagliflozin or a placebo similar to BI 690517 for at least six weeks while continuing any indicated ACEi or ARB treatments. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the remainder of the study. The study lasts about three to four years until enough events related to kidney or heart health occur. During the study, participants visit the study site about four times in the first six months and then every six months afterward. At these visits, doctors check health status, collect blood and urine samples, measure blood pressure and weight, assess kidney function, and monitor any side effects. Researchers track the time until worsening kidney disease, heart failure hospitalizations, or cardiovascular death to compare outcomes between treatment groups.
Actively Recruiting
Healthy Volunteer
This research aims to evaluate the effectiveness of a 12-session Heart Rate Variability Biofeedback HRV-BFB protocol in reducing distress and burnout while promoting psychological well-being among professionals of the Portuguese National Republican Guard GNR. These security forces face high occupational stress from unpredictable risks, shift work, and limited resources, which increases their vulnerability to chronic stress and related health issues. The study explores whether HRV-BFB can help improve autonomic regulation and emotional self-control in this high-stress group. Participants in the experimental group receive 12 individual HRV-BFB sessions over 4 weeks, with one 12-minute session every two days. The training uses a chest-worn ECG sensor connected to a mobile app that provides real-time visual feedback. The protocol guides participants through resonance frequency breathing and positive memory recall to increase heart rate variability and strengthen parasympathetic activity. A control group continues their usual duties without intervention during the same 4-week period and completes the same assessments. After study completion, control participants are offered the training. During the study, all participants undergo assessments at baseline, after 4 weeks, and at 10 weeks follow-up. Measurements include changes in psychological distress, occupational burnout, and psychological well-being using standardized scales. Additional heart rate variability indicators are recorded throughout training sessions for the experimental group. The study monitors participant adherence, autonomic responses, and psychological outcomes to assess the interventions impact over a total of 10 weeks from the start.
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