Orangeburg

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating finerenone compared to a placebo to assess the effectiveness and safety of treatment in patients with heart failure and reduced ejection fraction HFrEF who cannot tolerate or are not eligible for steroidal mineralocorticoid receptor antagonists sMRA. This international study is a randomized, double-blind, placebo-controlled trial focused on this specific group of heart failure patients. Participants will be randomly assigned to receive either oral finerenone or a matching placebo. The study uses a parallel design and treatment will be monitored for up to about 30 months. During this time, researchers will track cardiovascular events, heart failure events, and any serious or adverse events leading to discontinuation of the study drug. Throughout the study, participants will undergo regular assessments including symptom questionnaires and monitoring for cardiovascular outcomes and safety. The main outcomes include the time to the first cardiovascular death or heart failure event and the number of serious adverse events. The study also tracks changes in symptom scores over six months and overall survival. Participants will be followed closely during treatment and after to understand both efficacy and safety.

Researchers are evaluating the safety and effectiveness of the InnAVasc Arteriovenous Graft IG for patients with end-stage renal disease ESRD who require hemodialysis and need an arteriovenous graft for vascular access. The study aims to measure the proportion of patients maintaining secondary patency of the graft at 6 months and to monitor adverse events related to the device during this period. Participants will receive the InnAVasc Arteriovenous Graft surgically implanted in the forearm or upper arm using standard vascular surgical techniques. The graft can be placed in a straight configuration in the upper arm or in a looped configuration in the forearm or upper arm, avoiding placement across the elbow. Patients must be able to continue or start antiplatelet therapy after the implant. The study includes periodic follow-up visits and assessments for up to two years after implantation. During the study, participants will undergo assessments to monitor graft function, safety, and successful use for hemodialysis. Researchers will collect data on device patency, adverse events, and the ability to cannulate the graft within seven days of surgery. Follow-up evaluations will continue at multiple time points up to 24 months to assess sustained graft use and patient outcomes. Participants are expected to provide informed consent and attend all scheduled visits throughout the study duration.

The trial investigates the safety and effectiveness of Voyager Biomedicals Access Device designed to help patients undergoing routine hemodialysis by facilitating the cannulation of arteriovenous fistulas AVFs. This pivotal, interventional, single-arm, open-label study aims to support FDA clearance of the device by assessing its ability to improve access during dialysis and ensure patient safety. The study addresses challenges where AVFs are difficult to cannulate due to depth or accessibility issues and evaluates the device as a potential alternative to other surgical methods. Participants will have the VenaSure device surgically implanted at the dialysis access site, tailored to their clinical needs. Depending on vascular access conditions, one or two devices may be implanted to assist arterial andor venous cannulation. After implantation, patients will be observed for 6 weeks to allow healing. Following this, they will be monitored for 36 months while undergoing routine hemodialysis to assess the devices long-term performance and safety. During the study, participants will have regular follow-up visits to monitor healing, device function, and any adverse effects. Researchers will collect data on the devices ability to facilitate cannulation at 6 months and evaluate safety outcomes at 12 months and beyond. The study lasts approximately 48 to 60 months from enrollment until data collection is complete. Patients exit the study after the final visit with no ongoing device-related safety concerns.

Researchers are evaluating the efficacy and safety of AZD2373 in adults aged 18 to 70 years with APOL1-Mediated Kidney Disease AMKD who have high-risk APOL1 genotypes G1 and G2. The study aims to determine if AZD2373 reduces urine albumin-to-creatinine ratio UACR more than a placebo by Week 30. This Phase 2b trial involves participants with elevated UACR and adequate kidney function, excluding those on dialysis or with other organ transplants. The study consists of two parts. Part A randomizes participants equally to receive weekly subcutaneous injections of either 50 mg AZD2373, 150 mg AZD2373, or placebo. Part B randomizes participants in a 41 ratio to receive every-other-week injections of 150 mg AZD2373 or placebo, starting after Part A enrollment completes. Participants remain on treatment for a minimum of 30 weeks. After this period, they may enter an open-label extension study. Participants will have regular assessments throughout the study, including urine and blood tests to measure UACR, urine protein-to-creatinine ratio, kidney function eGFR, drug levels, and antibody development. Safety monitoring includes tracking adverse events during treatment and for 12 weeks afterward. These evaluations help assess how the study drug affects kidney disease markers and participant health over the treatment period.

Researchers are studying adolescents aged 12 to 17 years with chronic rhinosinusitis without nasal polyps to evaluate the effectiveness and safety of an intranasal medication called OPN-375 fluticasone propionate. This 12-week randomized, double-blind, placebo-controlled study aims to compare OPN-375 administered twice daily with a placebo. The main goal is to measure changes in symptoms like nasal congestion, facial pain, and nasal discharge by the end of Week 4. The study also includes a pharmacokinetic sub-study with up to 14 participants. Participants will be randomly assigned to one of two groups one receiving OPN-375 nasal spray 186 mcg twice a day, and the other receiving a matching placebo using the same delivery system. The double-blind treatment phase lasts 12 weeks. The pharmacokinetic sub-study is conducted openly in a smaller group to assess how the drug behaves in the body. During the approximately 15-week study, participants will have three on-site visits at screening, randomization, and study end Week 12. Telephone calls will take place at Weeks 4 and 8 to monitor progress. Assessments include symptom scoring using a daily diary and nasal symptom scales, with researchers tracking changes in symptom severity, frequency of acute flare-ups, quality of life, and patient impressions. Safety and compliance are monitored throughout the study.

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 observational study focuses on patients who require vascular access for hemodialysis. The device has been approved by the FDA and this study is not testing an experimental therapy or procedure. Participants will have an arteriovenous AV graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis in the upper arm. Since this is an observational study, no new treatments are assigned, and the study monitors the real-world use of the approved device over time. During the 2-year follow-up, researchers will track outcomes such as the incidence of treatment-emergent adverse events, graft patency how long the graft stays open, interventions needed to maintain graft function, and successful device use immediately after the procedure. Participants will follow their usual dialysis schedule and attend follow-up visits to assess safety and device performance throughout the study period.

Researchers are evaluating the EchoMarkEchoSure System for diagnostic ultrasound in patients with arteriovenous fistula AVF created for hemodialysis access. This randomized, multi-center trial aims to assess whether biweekly ultrasound assessments can better track fistula maturation and reduce the time until the fistula is ready for clinical use. The study involves adults with advanced kidney disease, including those on dialysis or approaching dialysis, who require upper arm AVF creation. Participants are divided into two groups. One group receives the EchoMark device implanted during fistula creation and undergoes EchoSure scans every two weeks to monitor fistula development until maturation or permanent access use. The other group follows the standard care protocol, including physical exams at about 2 weeks and 4 to 6 weeks post-surgery, with additional ultrasound assessments if abnormalities are detected. Both groups continue follow-up until fistula maturation or permanent access use, with visit frequency limits set by the study. During the study, participants will have regular assessments including physical exams, ultrasound scans, medical history reviews, and adverse event monitoring. Researchers will compare safety and effectiveness measures at 6 months, including ultrasound flow and size measurements, hospitalization rates, and costs. The study also tracks events related to fistula use and catheter removal. Participation may last several months, with ongoing monitoring to measure outcomes and device performance.

Researchers are evaluating the Velocity Percutaneous Arteriovenous Fistula pAVF System, a new minimally invasive device designed to create dialysis access for adults with kidney failure. This study aims to assess the safety and effectiveness of this catheter-based approach compared to traditional surgical methods. The study includes adults aged 18 to 80 years who require hemodialysis access or are expected to need it within six months. Participants will undergo the Velocity pAVF procedure, which creates an arteriovenous fistula through a small skin puncture without open surgery. After the procedure, they will be monitored with physical exams, duplex ultrasounds, and dialysis assessments to evaluate fistula maturation, usability, and long-term function. Any additional procedures needed to assist maturation or maintain access will be recorded. Safety monitoring will include tracking device- and procedure-related complications. During the study, participants will have follow-up visits for up to five years, during which their fistulas functional and physiological maturation will be assessed at specific intervals, including 6 weeks, 3 months, 6 months, and yearly thereafter. Researchers will measure outcomes such as time to first hemodialysis, catheter use duration, patency rates, and adverse events. This long-term follow-up will help gather information to improve dialysis access care.

Researchers are evaluating two treatment options for people with type 2 diabetes who also have established or high-risk atherosclerotic cardiovascular disease ASCVD. This clinical trial aims to compare the total number of heart, kidney, and death events between treatments using sodium-glucose cotransporter-2 inhibitors SGLT2i and glucagon-like peptide-1 receptor agonists GLP-1 RA. The study involves 6,000 participants and seeks to better understand how these medications affect health outcomes in this population. Participants will be randomly assigned to receive either an SGLT2 inhibitor canagliflozin, dapagliflozin, or empagliflozin or a GLP-1 receptor agonist dulaglutide, liraglutide, or semaglutide, all of which have shown cardiovascular benefits. The study is open label, meaning both participants and researchers know which treatment is given. Treatment assignment is balanced evenly between the two groups, and participants will continue their assigned therapy throughout the study. During the trial, researchers will monitor participants for events including heart attacks, strokes, arterial revascularization, hospitalizations for heart failure, kidney failure, kidney transplants, and death. Follow-up will last for an average of about three years. Data will be collected through medical records and electronic health information, with ongoing tracking of health status and treatment adherence to assess the total number of these cardiovascular and kidney-related events.