Chieri

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are collecting epidemiological data on adults newly diagnosed with myelodysplastic syndrome (MDS) to better understand the disease. The study aims to develop a network of Italian regional registries that use a unified electronic case report form to store patient data. This network will allow for the aggregation and analysis of anonymous data from different regions and enable combining this information with other international registries. There are no specific treatments or interventions in this study as it focuses on data collection and registry development. The main goal is to gather consistent and comprehensive epidemiological data through regional registries across Italy. Participants will have their diagnosis and related information recorded in the registry. Researchers will monitor outcomes over six years, including the incidence and prevalence of MDS, overall response rates, survival rates, progression-free survival, and progression to acute myeloid leukemia (AML). The study involves long-term follow-up to track these outcomes and improve understanding of MDS epidemiology.