Iwata

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 AGN1 LOEP, a local osteo-enhancement procedure, to prevent secondary hip fractures in osteoporotic women who have already had an initial hip fracture and surgery. This randomized controlled trial involves postmenopausal women aged 65 to 91 years who experienced a low-energy fragility hip fracture. The study aims to reduce the chance of a second hip fracture by comparing the new treatment to standard care alone. Participants will be randomly assigned to one of two groups the treated group receives standard hip fracture repair plus the AGN1 LOEP procedure on the opposite unfractured hip, while the control group receives standard repair without the AGN1 LOEP treatment. The AGN1 LOEP procedure involves injecting implant material into the unfractured hip immediately after surgery. This study is single-blinded, except in Canada where it is not blinded. Participants will attend scheduled follow-up visits at 6 weeks, 6 months, and every 6 months thereafter for at least 5 years. During these visits, researchers will monitor for new hip fractures, adverse events, and measure bone mineral density at 12 and 24 months. The study will assess the cumulative incidence of secondary hip fractures and safety outcomes over time, with a minimum follow-up of 5 years after the initial hip repair surgery.