Bihorel

This is a long-term follow-up trial to the post-authorisation efficacy and safety (PAES) trial (trial 20-HMedIdeS-19). The trial will include patients who participated in the PAES trial and were transplanted with a new kidney after treatment with imlifidase (trial drug) or standard of care medication. Imlifidase is a medicine used to prevent the body from rejecting a newly transplanted kidney and is used before transplantation in adults who have antibodies against the donor kidney and are considered 'highly sensitised' based on a positive crossmatch test. The purpose of this follow-up trial is to fulfil requirements from the European Medicines Agency (EMA) to continue to evaluate efficacy (kidney function) and safety (side effects) over time, for the patients who were transplanted with a new kidney in the PAES trial. The patients will be followed for up to 5 years after transplantation in the PAES trial to collect valuable long-term data.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the safety, tolerability, and effectiveness of baxdrostat compared to a placebo in reducing seated blood pressure and normalizing the Renin Angiotensin Aldosterone System (RAAS) in adults aged 18 years and older diagnosed with Primary Aldosteronism (PA). This Phase III, multicenter, randomized, double-blind, placebo-controlled study aims to include about 180 participants, some of whom may have prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. Participants will be randomly assigned to receive either baxdrostat tablets or matching placebo tablets once daily. The dose may be increased after two weeks depending on clinical response and tolerability. The study is conducted in approximately 90 centers across 12 countries, providing a broad and diverse participant base. During the study, researchers will closely monitor seated systolic blood pressure and RAAS normalization at week 8 to assess the treatment effects. Participants will also undergo laboratory tests including serum potassium and sodium levels, kidney function evaluation, and blood pressure measurements. Safety and tolerability will be assessed throughout the study period, ensuring comprehensive monitoring of participants' health and response to treatment.

Researchers are comparing the effects of Gastric By-Pass surgery to optimized medical treatment in adults with obesity and poorly controlled type 2 diabetes. The study aims to evaluate differences in mortality, weight loss, blood sugar control, quality of life, costs, and cost-effectiveness between these two strategies. Type 2 diabetes is a major health concern with significant mortality and economic impact, and while current medical treatments improve metabolic control, their effect on mortality is limited. Bariatric surgery, such as Gastric By-Pass, has shown promise in improving diabetes outcomes and reducing cardiovascular risks in obese patients. Participants will be assigned to either receive laparoscopic Roux-en-Y Gastric By-Pass surgery or optimized medical management including therapies like GLP-1 analogues or insulin. The surgery involves a permanent reduction of excess weight and an intestinal bypass, which may improve insulin secretion beyond weight loss alone. Medical management will be tailored to optimize treatment for each participant. The study is prospective, multicenter, randomized, and conducted in a Phase 4 setting. During the study, participants will be closely monitored for up to five years to assess overall mortality as the primary outcome. Researchers will also track weight changes, blood sugar control, and quality of life, as well as analyze costs and cost-effectiveness of both treatments. The study includes careful screening and follow-up assessments to ensure safety and gather comprehensive data on long-term outcomes.

Researchers are evaluating the impact of the mylife CamAPS FX hybrid closed-loop insulin delivery system combined with the DEXCOM G6 Continuous Glucose Monitoring sensor on blood sugar control in people with type 1 diabetes in real-life conditions in France. This non-interventional, multicenter, prospective study aims to assess glycemic control after one year of use, along with participant-reported outcomes like quality of life, treatment satisfaction, fear of low blood sugar, and sleep quality. The study is conducted under post-market clinical follow-up regulations without invasive procedures. Participants will use the mylife CamAPS FX system with the DEXCOM G6 sensor for one year while being monitored by diabetes specialists at 20 centers across France. The study does not involve additional interventions; it is observational, collecting data on system usage patterns such as Boost/Ease-Off mode use, insulin-to-carbohydrate ratios, and alarms. Approximately 125 participants, including 100 adults and 25 minors, will be followed throughout the study period. Participants will have data collected at three time points during the year to monitor changes in time spent in the target blood sugar range. Specialists will also track complications related to the system and gather information through questionnaires about participants' experiences and satisfaction. The study focuses on real-life effectiveness and safety of the device, with continuous monitoring over 12 months after system initiation.

Researchers are evaluating the effects of baxdrostat combined with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Researchers are investigating the safety, tolerability, how the body processes, immune response, and anti-cancer effects of volrustomig combined with other cancer drugs in adults with certain solid tumors, including non-small cell lung cancer (NSCLC). This Phase II, open-label, multicenter platform study focuses on evaluating these combinations in different types of NSCLC. The study includes participants with metastatic non-small cell lung cancer, divided into substudies and treatment groups based on tumor characteristics. Participants will receive volrustomig through intravenous (IV) infusion along with other anticancer drugs such as carboplatin, pemetrexed, ramucirumab, or paclitaxel, also given by IV. The study has two substudies: one for metastatic non-squamous NSCLC with randomization between two treatment arms, and another for metastatic squamous or non-squamous NSCLC enrolling in a single arm. All treatment arms test volrustomig dosing combined with chemotherapy. Throughout the study, participants will be monitored for side effects, immune reactions, and tumor responses for up to nearly three years. Researchers will track adverse events and serious adverse events from screening through the follow-up period, as well as measure objective tumor responses. The study involves regular assessments to evaluate safety, drug effects, and cancer activity during and after treatment.