Ragama

Researchers are evaluating a combination therapy of finerenone plus empagliflozin compared to usual care in patients hospitalized with heart failure. This international, randomized, controlled, open-label trial aims to assess the effectiveness and safety of this early, intensive treatment approach in managing heart failure during and after hospitalization. Participants will either receive the combination of oral finerenone and empagliflozin or continue with usual care management. The study is designed to compare these two approaches to determine their impact on clinical outcomes. The trial includes a treatment period with these medications given alongside usual management during hospitalization and follow-up. During the study, participants will be monitored over six months for clinical benefits and safety outcomes such as serious adverse events and adverse events leading to discontinuation. Researchers will assess heart failure events, symptom changes using the Kansas City Cardiomyopathy Questionnaire, and time to death or heart failure events. Study visits and evaluations will track participant health and response to treatment over this period.

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.

Researchers are evaluating finerenone compared to a placebo to assess the effectiveness and safety of treatment in patients with heart failure and reduced ejection fraction HFrEF who cannot tolerate or are not eligible for steroidal mineralocorticoid receptor antagonists sMRA. This international study is a randomized, double-blind, placebo-controlled trial focused on this specific group of heart failure patients. Participants will be randomly assigned to receive either oral finerenone or a matching placebo. The study uses a parallel design and treatment will be monitored for up to about 30 months. During this time, researchers will track cardiovascular events, heart failure events, and any serious or adverse events leading to discontinuation of the study drug. Throughout the study, participants will undergo regular assessments including symptom questionnaires and monitoring for cardiovascular outcomes and safety. The main outcomes include the time to the first cardiovascular death or heart failure event and the number of serious adverse events. The study also tracks changes in symptom scores over six months and overall survival. Participants will be followed closely during treatment and after to understand both efficacy and safety.

Chronic kidney disease CKD affects over 800 million people worldwide and is expected to become the fifth leading cause of death by 2040. This trial investigates various treatments to find the best options or combinations that slow CKD progression and reduce the risk of kidney failure and related complications. The study is a Phase III, international, multi-center, adaptive, platform trial designed to answer multiple treatment questions efficiently within a common setup. Participants receive study treatments, such as finerenone tablets 10mg or 20mg or matched placebo tablets, taken orally once daily. Each treatment period lasts 2 years, with follow-up visits scheduled at about 1 month, 3 months, 6 months, 12 months, 18 months, and 2 years after starting treatment. A final visit occurs one month after completing the 2-year treatment phase. The trial is ongoing and allows participants to join multiple treatment arms either simultaneously or at different times. During the study visits, researchers collect blood and urine tests, evaluate safety, and monitor treatment adherence. Overall health status is assessed every 5 years. The main outcome measured is the change in kidney function eGFR slope from the start of treatment to week 108. Secondary outcomes include changes in albuminuria, kidney failure events, mortality, cardiovascular events, safety, and quality of life. The trial plans long-term follow-up and safety monitoring over several years.