Anjo

Researchers are evaluating the safety and effectiveness of rituximab (genetical recombination) given through an intravenous infusion for people with idiopathic membranous nephropathy who also have nephrotic syndrome. This phase 3 study aims to confirm how well rituximab works and how safe it is compared to a placebo. The study focuses on patients aged 15 years and older who meet specific clinical criteria related to their kidney condition and protein levels. Participants will receive either rituximab or a placebo through intravenous infusions given every two weeks for two doses during the double-blind phase. If patients do not show sufficient improvement by week 26, they may enter an open-label phase where they can receive rituximab again if deemed necessary by the investigator. The treatment dosing in the open-label phase is the same as in the initial phase, with two doses of 1,000 mg rituximab given every two weeks. During the study, participants will be monitored to measure the percentage of patients achieving predefined remission criteria by week 26. Assessments will likely include lab tests for protein levels and albumin in the blood, kidney function, and safety evaluations. The study involves informed consent, screening for eligibility, and ongoing monitoring to evaluate treatment response and safety throughout the study period.

Researchers are evaluating the early use of a once-daily oral drug called empagliflozin 10 mg in patients hospitalized with acute heart failure (AHF) who are at high risk for serious complications. This multicenter, randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the efficacy and safety of empagliflozin compared to a matching placebo in this patient group. The trial focuses on patients requiring intravenous diuretic therapy and exhibiting specific clinical signs and biomarker levels related to heart failure severity. Participants are randomly assigned to receive either empagliflozin 10 mg once daily or a placebo shortly after hospital admission. Treatment begins within 12 hours of hospital presentation and continues during the hospitalization period. The study excludes patients with very low kidney function, recent use of similar drugs, certain heart conditions, and other specific medical issues to ensure safety and clear evaluation of the drug's effects. During the study, patients will be closely monitored for outcomes including death, rehospitalization for heart failure, worsening heart failure during the hospital stay, and urine output within 48 hours of treatment start. Researchers will use a combined measure called the win ratio to assess these outcomes over 90 days. Participants will undergo clinical evaluations, laboratory tests, and safety assessments throughout the study period to track the drug's impact and monitor for any adverse events.

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.