Yaizu

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 studying the effectiveness of riliprubart compared to intravenous immunoglobulin IVIg in adults with Chronic Inflammatory Demyelinating Polyneuropathy CIDP who are already receiving IVIg maintenance treatment. This Phase 3 trial aims to evaluate how well riliprubart works and its safety over a study period lasting up to 109 weeks, including screening, treatment, and follow-up phases. Participants are randomly assigned to one of two groups one receives riliprubart along with a placebo IVIg infusion for 24 weeks, followed by a 24-week open-label extension phase where all receive riliprubart the other group continues IVIg treatment with a placebo riliprubart for 24 weeks, then also enters the open-label extension phase receiving riliprubart. The study uses intravenous and subcutaneous solutions for administration and includes a double-blind design to compare treatments fairly. During the study, participants undergo various assessments including disability scales, grip strength measurements, fatigue scales, and health quality evaluations from baseline up to week 48 and beyond. Researchers will monitor treatment responses, relapses, adverse events, and immune responses throughout the trial. Participants are followed closely for safety and effectiveness until the study concludes, with total involvement lasting up to 109 weeks.

Researchers are evaluating the efficacy and safety of AZD5148, a monoclonal antibody, for preventing the recurrence of Clostridioides difficile infection in adults aged 18 and older. This Phase IIb study aims to compare a single dose of AZD5148 with a placebo to better understand its potential role in reducing recurrent infections. The study involves approximately 230 participants randomized equally to receive either the active drug or placebo. Participants will receive one dose of AZD5148 or placebo, administered either by intramuscular injection or intravenous push based on the investigators choice. The study includes up to two site visits for eligibility confirmation and dose administration, including stool sample collection. Following treatment, there will be up to seven planned visits with weekly contacts initiated by the study staff, transitioning later to monthly follow-ups. Participants will also complete an electronic diary to record relevant information. During the study, participants will undergo various assessments including stool testing, monitoring of diarrhea symptoms, and evaluation of any recurrence of infection up to 91 days after dosing. Safety assessments will include monitoring for immediate and delayed adverse events, injection site reactions, and serious adverse events up to 361 days. Pharmacokinetics and immune response to AZD5148 will also be evaluated. The total participation period spans from initial screening through follow-up visits extending up to nearly one year after treatment.