Orangeburg

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

This trial investigates the safety and effectiveness of risankizumab compared to vedolizumab in adults with moderate to severe ulcerative colitis (UC) who have not previously received targeted therapies. Ulcerative colitis is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. The study is a Phase 3b, randomized, open-label trial enrolling about 530 participants across 285 sites worldwide. Participants will be randomly assigned to receive either risankizumab or vedolizumab. Those in the risankizumab group will receive the drug intravenously during the initial induction phase, followed by subcutaneous injections for maintenance. Participants in the vedolizumab group will receive the drug intravenously throughout the study. The treatment period lasts 44 weeks for risankizumab and 46 weeks for vedolizumab, following a screening period of up to 35 days. During the study, participants will attend regular outpatient visits for medical assessments, side effect evaluations, and to complete questionnaires. Researchers will monitor disease activity and drug safety, focusing on the percentage of participants achieving endoscopic improvement by week 48. The total study duration is approximately 69 weeks for risankizumab and 71 weeks for vedolizumab recipients.

Researchers are evaluating the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis access in patients with end-stage renal disease (ESRD). The study focuses on patients who require hemodialysis and for whom an arteriovenous graft is the next best option for vascular access. The main goals include measuring the proportion of patients whose graft remains open (secondary patency) at 6 months and monitoring device-related adverse events over the same period. Participants will receive the InnAVasc Arteriovenous Graft implanted in either the forearm or upper arm using standard vascular surgical methods. The graft placement may be a straight "soft C" configuration in the upper arm or a looped configuration in the forearm or upper arm, but it cannot cross the elbow. Patients must be able to take antiplatelet therapy as directed by their doctor. The study includes follow-up visits and assessments for up to 2 years after the graft implant. During the study, participants will undergo regular evaluations including monitoring the graft's function and safety through clinical assessments. Researchers will track adverse events and measure graft patency at 6 months as primary outcomes. Patients will be asked to provide informed consent and will participate in periodic visits and assessments to ensure proper monitoring of their condition and the device's performance throughout the study period.

The trial investigates the safety and effectiveness of Voyager's Access Device, called VenaSure, designed to aid cannulation of arteriovenous fistulas (AVFs) in patients undergoing routine hemodialysis. This pivotal, prospective, single-arm, open-label study aims to support FDA clearance by demonstrating the device's ability to facilitate AVF cannulation and assessing its safety over time. The study focuses on patients with vascular access complications related to dialysis treatment. VenaSure is surgically implanted at the access site to provide a target that helps improve long-term cannulation success. After implantation, participants are observed for 6 weeks to allow the implant site to heal. Following this, they continue routine dialysis treatments while being monitored for 36 months. The study will conclude after the final visit when no device-related adverse events are being monitored. Participants will undergo assessments including ultrasound measurements and monitoring of dialysis procedures during the study period. Effectiveness is primarily measured by the device's ability to facilitate AVF cannulation over 6 months, while safety is evaluated for up to 12 months after implantation. The study is expected to last approximately 48 to 60 months from the first enrollment until all data collection is complete.

Researchers are evaluating the safety and effectiveness of AZD2373 in adults aged 18 to 65 diagnosed with APOL1-Mediated Kidney Disease (AMKD) who carry specific high-risk APOL1 genotypes (G1 and G2). This Phase 2b study aims to see if AZD2373 can reduce the urine albumin-creatinine ratio (UACR) more than a placebo by the 30th week of treatment. Participants must have significant kidney involvement as indicated by UACR and estimated glomerular filtration rate (eGFR) levels. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple treatment groups. The study includes three treatment arms: two different doses of AZD2373 and a placebo, all delivered via accessorized pre-filled syringes as injections. Participants will be randomly assigned to one of these groups and neither they nor the study staff will know their assignment during the trial. Treatment will last for a minimum of 30 weeks, continuing until the last participant completes this period. The study also uses a specialized APOL1 genotyping test to confirm participants' eligibility based on their genetic profile. Participants will undergo screening with urine tests to confirm UACR levels and blood tests for kidney function before joining. During the study, researchers will monitor changes in UACR from baseline to week 30 to assess treatment effects. Safety and tolerability will also be closely observed throughout the treatment period. Around 96 participants will be enrolled, with about 32 in each group, and all will be followed until the last participant completes the 30 weeks of treatment.

Researchers are evaluating the effectiveness and safety of an intranasal spray called OPN-375 (fluticasone propionate) at a dose of 186 mcg twice daily in adolescents aged 12 to 17 years who have chronic rhinosinusitis without nasal polyps. This Phase 3, 12-week, randomized, double-blind, placebo-controlled study includes approximately 84 participants who will be assigned to either the OPN-375 treatment or a placebo in equal numbers. A pharmacokinetic sub-study will also be conducted with up to 14 participants to assess how the drug is processed in the body. Participants will undergo a 7 to 21 day screening period before starting the 12-week double-blind treatment phase. They will receive the study drug or placebo via an exhalation delivery system twice daily throughout this period. The study involves three on-site visits at screening, randomization, and at the end of the 12-week treatment, along with two telephone check-ins at weeks 4 and 8. The pharmacokinetic sub-study is conducted openly within this framework. During the study, participants will complete daily diaries to track nasal symptoms such as congestion, facial pain or pressure, and nasal discharge. These symptoms are scored to assess treatment effects, particularly focusing on changes from baseline to week 4. Safety and efficacy will be monitored through nasal examinations, symptom scoring, and scheduled visits and calls, with total participation lasting about 15 weeks.

Researchers are collecting long-term safety and performance data on the EndoForce System, a device used to connect a hemodialysis graft to a vein in patients with End Stage Renal Disease (ESRD). This study is observational and involves a device that has already been approved by the FDA, meaning it is not testing an experimental procedure or therapy. The study focuses on patients who need a vascular access graft placed in their upper arm for hemodialysis. The EndoForce System is used for this connection process. There are no experimental treatments or comparator groups since this is a post-approval study of the device's use in real-world settings. Participants will be followed for up to two years to monitor various outcomes including the rate of treatment-emergent adverse events, average cumulative and primary patency of the graft, the number of interventions needed to maintain patency, and the success of the device during the procedure. Researchers will collect safety and performance data through these measures while participants continue with their regular dialysis schedule and follow-up visits.

Researchers are evaluating the use of the EchoMark/EchoSure System for diagnostic ultrasound in patients with diabetes and end-stage renal disease undergoing arteriovenous fistula (AVF) creation for hemodialysis access. This prospective, multi-center, randomized trial compares the performance of this automated sonography system used biweekly to assess fistula maturation and potentially reduce the time to clinical maturation against the current standard of care. The study aims to improve monitoring of fistula development in patients who require reliable vascular access for dialysis. Participants in the Diagnostic Arm will have the EchoMark device implanted during AVF creation and undergo EchoSure scans every two weeks. These scans help investigators decide when further physical exams or interventions are needed to support fistula maturation. Physical exams include checking for bruit and thrill, and medical history is reviewed at each visit regarding interventions and adverse events. The Standard of Care Arm participants receive follow-up assessments per KDOQI guidelines, including physical exams at 2 weeks and 4-6 weeks, with additional ultrasound and treatment as needed based on clinical findings. Follow-up visits in this arm occur no more than once per month until fistula maturation or permanent access use. Throughout the study, participants will attend scheduled visits for assessments including physical exams, medical history reviews, and ultrasound scans as applicable. Researchers will monitor safety and effectiveness endpoints over six months. Adverse events, cannulation attempts, and laboratory results will be tracked. The study requires participants to comply with follow-up visits and evaluates the time to clinical maturation of the fistula, aiming to enhance dialysis access outcomes. Total participation lasts through the fistula maturation period and includes safety monitoring over six months.

Researchers are evaluating two different medication classes for patients with type 2 diabetes who have established atherosclerotic cardiovascular disease (ASCVD) or are at high risk for ASCVD. This Phase 4 clinical trial aims to compare the total number of cardiovascular events, kidney events, and deaths between treatments using sodium-glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA). The study plans to enroll 6,000 participants and follow them to assess the occurrence of heart attacks, strokes, arterial procedures, heart failure hospitalizations, kidney failure treatments, and mortality. Participants will be randomly assigned to receive either SGLT2 inhibitors (empagliflozin, dapagliflozin, or canagliflozin) or GLP-1 receptor agonists (dulaglutide, liraglutide, or semaglutide). The trial compares these two medication types in a 1:1 ratio. Patients will continue their usual diabetes care with adjustments for safety, and those already taking one of the study medication classes may stop their current drug to be randomly assigned. The trial uses an open-label, pragmatic design reflecting real-world treatment. During the study, researchers will monitor participants for the total number of cardiovascular and kidney-related events as well as deaths over an average follow-up period of about three years. Data collection will include medical records accessed via electronic health records and medical releases. Outcomes include heart attacks, strokes, arterial revascularization, heart failure hospitalizations, kidney failure events, kidney transplants, and mortality. Safety and adherence will be regularly assessed throughout the study period.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.