Lufkin

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 evaluating inclisiran, a subcutaneous injection given twice yearly, to see if it can prevent major cardiovascular and limb events in patients undergoing percutaneous coronary or peripheral arterial revascularization. This Phase 4, randomized, double-blind study includes patients with symptomatic coronary artery disease or peripheral artery disease who have recently had successful revascularization procedures. The trial aims to assess the real-world effectiveness of inclisiran alongside usual care in a typical U.S. patient population with atherosclerotic cardiovascular disease. Participants will be randomly assigned to receive either 300 mg inclisiran or a matching placebo by subcutaneous injection on Day 1, Month 3, and then every 6 months thereafter. The first dose is given within 14 days of a successful percutaneous coronary or peripheral endovascular intervention. Both groups will continue to receive standard medical care as directed by their physicians. The study plans to enroll about 6,000 participants and treatment duration may last up to approximately 45 months. During the study, researchers will monitor participants for the occurrence of major adverse cardiovascular events and major adverse limb events for up to about 4 years. Participants will have regular follow-up visits and safety assessments throughout the study period, which is designed to continue until around 2,380 primary events have occurred or at least half the participants have completed 36 months of follow-up. Outcome measures focus on the number of cardiovascular and limb events after the procedures, providing important information on the long-term impact of inclisiran in this patient group.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in patients who have elevated lipoprotein(a) levels and established atherosclerotic cardiovascular disease (ASCVD). It is an open-label, non-randomized rollover extension study involving participants who have completed previous double-blind parent studies related to pelacarsen treatment. Participants will receive pelacarsen 80 mg administered subcutaneously once a month during this extension phase. The study offers continued access to pelacarsen for those who successfully finished the parent studies, allowing researchers to monitor its effects over a longer period. Throughout the study, participants will be monitored for adverse events and serious adverse events for up to 48 months. Researchers will assess safety and tolerability through ongoing evaluations, ensuring continuous observation of participants' health and responses to the treatment during this extended timeframe.