Carnaxide

Researchers are evaluating the safety, tolerability, and effectiveness of two treatments, inebilizumab and blinatumomab, in adults with active and difficult-to-treat autoimmune diseases. This includes systemic lupus erythematosus (SLE) with nephritis, SLE with and without nephritis, and active refractory rheumatoid arthritis (RA). The study is a Phase 2, open-label, multicenter platform trial designed to assess these treatments across different subprotocols based on the specific condition and disease activity. Participants receive inebilizumab through intravenous infusion or blinatumomab via subcutaneous injection, depending on their assigned subprotocol. The study includes several parts: Subprotocol A focuses on SLE with nephritis treated with inebilizumab; Subprotocol B Part A and Part B assess blinatumomab in SLE with and without nephritis; and Subprotocol C Parts A and B evaluate blinatumomab in rheumatoid arthritis. The treatments are administered over specified periods, with some groups receiving treatment for up to 52 weeks. During the trial, participants undergo various assessments to monitor safety and disease response, including evaluation of treatment-emergent adverse events, serious adverse events, and measures of disease remission or activity. For example, kidney response and remission in SLE and disease activity scores in RA are measured at specific time points. Safety monitoring continues through the treatment period, with data collected on adverse events from Day 1 to Week 52. Participants' health status, laboratory tests, and disease activity are regularly evaluated to understand the treatments' effects and tolerability.

Researchers are studying the effects of DMX-200 (repagermanium), a drug that blocks a receptor involved in inflammation, in people with focal segmental glomerulosclerosis (FSGS) who are also taking an angiotensin II receptor blocker (ARB). This Phase 3 trial aims to assess the safety and effectiveness of DMX-200 compared to placebo over 104 weeks in adults and adolescents aged 12 to 17 years. Following the initial study, an open-label extension will evaluate long-term safety and benefits for up to two more years. Participants will be randomly assigned to receive either DMX-200 at 120 mg twice daily or a placebo, while continuing their ARB treatment. The study includes a screening and qualification period lasting 6 to 14 weeks, a 104-week double-blind treatment phase, and a 4-week follow-up after treatment. Those completing this phase may enter the open-label extension for an additional minimum of 104 weeks, with another 4-week follow-up period, making the total study duration about 230 weeks. During the trial, participants will undergo regular assessments including urine protein and creatinine testing, kidney function monitoring by estimated glomerular filtration rate (eGFR), and safety evaluations. The main outcomes measured are changes in proteinuria, kidney function slope up to week 104, and long-term safety through week 216. Safety will be closely monitored throughout both the double-blind and extension periods to understand the drug's effects over time.

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 finerenone, a drug that blocks a protein involved in inflammation and scarring, to see if it helps children with heart failure and left ventricular systolic dysfunction (LVSD). Heart failure is a serious condition where the heart cannot pump enough blood, causing symptoms like shortness of breath, fatigue, and poor growth. This Phase 3 study is the first to explore finerenone's effects specifically in children aged 6 months to under 18 years with these heart problems. The goal is to determine if finerenone improves heart function compared to a placebo by measuring levels of a heart stress protein called NT-proBNP and monitoring safety. Participants will be randomly assigned to receive either finerenone or a placebo for about 90 days, while continuing their standard heart failure treatments. The study includes a double-blind design, meaning neither the participants nor the researchers know who receives the active drug or placebo during this period. After the initial three-month treatment, eligible participants may join a nine-month open-label extension where all receive finerenone. Those not entering the extension will have a follow-up visit 30 days after finishing treatment. Throughout the study, participants will visit the study site at least three times for assessments including vital signs, heart exams with ECG and echocardiogram, blood tests, physical exams, and interviews about their medication and any medical problems. Researchers will track all adverse events, which are any health issues occurring during the study, regardless of relation to the treatment. The main outcome measured is the change in NT-proBNP from the start to the end of treatment, helping to evaluate the drug's effect on heart stress.

Researchers are collecting clinical data to evaluate the ongoing safety and performance of commercially approved Biosense Webster Inc. (BWI) medical devices used in standard cardiac arrhythmia mapping and ablation procedures. The study focuses on patients diagnosed with cardiac arrhythmias such as atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia. The goal is to confirm safety and performance of these devices in real-world use and to expand the evidence on their application in treating arrhythmias. Participants will be treated with commercially approved BWI medical devices following routine clinical practice. Sub-studies include participants treated with the Varipulse Catheter and the Dual Energy THERMOCOOL SMARTTOUCH SF Catheter. No specific intervention or experimental procedure will be imposed for the study; the treatments follow standard care procedures. During the study, researchers will monitor safety by tracking adverse events related to the devices or procedures within seven days of treatment. They will also assess treatment effectiveness by evaluating specific outcomes such as isolation of pulmonary veins, non-inducibility of targeted tachycardias, and elimination of ventricular arrhythmias. Follow-up and compliance with standard hospital testing and care are expected as part of the participant involvement.

Researchers are evaluating a personalized prevention program (PPP) for people with stable coronary heart disease (CHD) who are at high risk for cardiovascular (CV) events. This prospective clinical study has two parts: Part A involves screening 12,000 CHD patients to validate biomarkers that predict CV events and identify those at highest risk. Part B is a randomized clinical trial with 2,000 high-risk patients comparing the PPP to usual care (UC) to assess the program's clinical value and cost-effectiveness. In the PPP group, participants will attend six visits over three years to receive lifestyle coaching and exercise prescriptions guided by trained staff and supervised by investigators. These sessions are supported by digital tools called the CoroPrevention Tool Suite. The study also monitors medication use and adherence through these visits. The usual care group will receive standard treatment without the personalized program. Throughout the study, participants will undergo biomarker testing, responses to questionnaires on nutrition and exercise, and assessments of heart health outcomes such as CV death, heart attacks, or heart failure events. Researchers will also evaluate behavioral changes, exercise adherence, medication use, and user experiences with the digital tools. The study includes follow-ups at multiple time points, lasting three years to measure the impact of the personalized prevention program compared to usual care.

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 evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are evaluating the safety and effectiveness of the Myval Transcatheter Heart Valve (THV) Series compared to Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis. This prospective, randomized, multinational, and open-label trial involves 768 participants, evenly divided between the two treatment groups, using a transfemoral approach for valve replacement. Participants will receive either the Myval THV Series or one of the Contemporary Valves, with device sizes ranging from 20 mm to 29 mm for Myval and Sapien series, and 23 mm to 34 mm for the Evolut series. The study includes non-randomized registries for patients requiring extra-large Myval valve sizes and for initial lead-in cases performed under guidance before randomization. Throughout the study, participants will be monitored for safety and effectiveness outcomes, including the Primary Combined Safety and Effectiveness Endpoint defined by the Valve Academic Research Consortium-3 within 30 days post-procedure. Researchers will assess valve function and patient health to compare the performance of the devices, with follow-up evaluations conducted to ensure thorough safety monitoring.

The purpose of this trial is to determine the safety and effectiveness of the Vienna Aortic Valve SE System, a new self-expanding transcatheter heart valve, in patients with symptomatic severe aortic stenosis (SSAS). This is a prospective, single arm, multicenter study in an expanding cohort of symptomatic patients with severe aortic stenosis following the FIH feasibility study. The clinical investigation comprises 11 visits (V1 to V11). After implantation of the IMD at visit 2, safety and effectiveness assessment of the device will be performed at 30 days (V4), 3 months (V5), 6 months (V6), 1 year (V7) and every year thereafter up to 5 years post-implantation (V8 to V11). In summary, the clinical investigation for the individual patient will end after 5 years with a full clinical evaluation. The primary study endpoints for safety and effectiveness will be reached at 30-day follow-up timepoint. The clinical trial is completed after all 267 patients, that are not prematurely withdrawn, have completed their 5-year follow-up visit involving all specified assessments.