Chieri

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are collecting epidemiological data on adults newly diagnosed with myelodysplastic syndrome MDS through a regional network of registries in Italy. The study aims to use a standardized electronic case report form to gather and anonymously share data across regions and with other international MDS registries. This observational study helps better understand the incidence, prevalence, and progression of MDS over time. Participants are adults diagnosed with MDS who consent to share their medical data. The study does not involve any treatment or intervention but focuses on data collection and monitoring through regional registries. The network facilitates aggregation and analysis of anonymous epidemiological information to support research and improve knowledge on MDS. During the study, researchers will track key outcomes over six years, including new MDS diagnoses, response rates, prevalence, overall survival, progression-free survival, and progression to acute myeloid leukemia AML. Participants information will be collected and stored securely without altering standard medical care. The study is expected to continue until May 2032, with ongoing data collection and long-term follow-up.