Illes Balears

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating linvoseltamab, an experimental drug also called REGN5458, in adults with multiple myeloma that has returned or needs treatment again after one to four prior therapies. The study compares linvoseltamab to a combination of three cancer drugs elotuzumab, pomalidomide, and dexamethasone EPd. This phase 3 study aims to assess the safety and effectiveness of linvoseltamab versus EPd in participants who have standard treatment options available and have previously received certain therapies including lenalidomide and a proteasome inhibitor. Participants are randomly assigned to one of two groups one receiving linvoseltamab by intravenous infusion, and the other receiving the EPd combination, with elotuzumab given by infusion and pomalidomide and dexamethasone given by mouth or infusion. The study focuses on how long participants benefit from the treatments, the degree of tumor response, side effects, survival, and pain improvement. During the study, participants will undergo regular assessments including disease response evaluations based on established criteria, safety monitoring, and patient-reported outcomes like pain and quality of life questionnaires. The primary measure is progression-free survival over up to about five years. Researchers will also track overall survival, adverse events, antibody responses, and other health status measures. Participation involves treatment, follow-up visits, and ongoing monitoring to understand the treatments impact.