Newry

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 evaluating whether metformin, a medication commonly used for diabetes, can be repurposed to slow kidney function decline in adults diagnosed with early-stage Autosomal Dominant Polycystic Kidney Disease ADPKD. ADPKD causes cyst growth in kidneys leading to pain, high blood pressure, chronic kidney disease, and reduced quality of life. This global Phase III randomized controlled trial aims to find effective, affordable treatments to reduce illness impact and improve life quality for ADPKD patients. Participants are randomly assigned to receive either extended-release metformin Metformin XR or a placebo, alongside standard care, for 104 weeks. The metformin dose ranges from 500 to 2000 mg daily based on individual tolerance and kidney function. The study includes a control group receiving identical placebo tablets for comparison. This design allows assessment of metformins effect on slowing disease progression. During the study, participants undergo regular monitoring including kidney function tests, assessment of kidney disease progression, quality of life questionnaires, and tracking of side effects and healthcare use over 24 months. The primary outcome is the change in estimated glomerular filtration rate eGFR. Secondary outcomes include kidney failure, mortality, medication dosing changes, and symptoms related to ADPKD. Safety and effectiveness are carefully followed throughout the trial period, which may last until 2030.